Trial Outcomes & Findings for Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (NCT NCT02278341)
NCT ID: NCT02278341
Last Updated: 2024-11-27
Results Overview
Baseline Hb was defined as the mean of four central laboratory Hb values; four latest Hb values prior or on the same date as the first study drug intake. For participants who did not have an available Hb value during the week 28-36 period, imputation rules were applied. For analyses without rescue therapy, participants who used rescue therapy after the initiation of rescue therapy were set to missing for 6 weeks from the start date of rescue therapy. If no Hb value was available, an imputation technique was used, with the mean of all available values from Day 1 to minimum (End of Efficacy Emergent Period) carried forward.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
838 participants
Primary outcome timeframe
Baseline and weeks 28 to 36
Results posted on
2024-11-27
Participant Flow
Study population consisted of participants with end-stage renal disease (ESRD) who were on stable hemodialysis (HD) or peritoneal dialysis (PD), and were also on stable treatment with epoetin (i.e. epoetin alfa, beta, theta, zeta, delta or omega) or darbepoetin alfa for anemia.
Participants were randomized in a 1:1 ratio to roxadustat or ESA (epoetin alfa or darbepoetin alfa). Randomization was stratified by 5 factors: previous ESA treatment, region, history of cardiovascular, cerebrovascular or thromboembolic diseases, average weekly ESA dose 4 weeks prior to randomization and the screening hemaglobin (Hb) value.
Participant milestones
| Measure |
Roxadustat
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Overall Study
STARTED
|
415
|
421
|
|
Overall Study
Received Treatment
|
414
|
420
|
|
Overall Study
COMPLETED
|
297
|
329
|
|
Overall Study
NOT COMPLETED
|
118
|
92
|
Reasons for withdrawal
| Measure |
Roxadustat
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Overall Study
Randomized but never received study drug
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Death
|
68
|
56
|
|
Overall Study
Withdrawal by Subject
|
30
|
19
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Miscellaneous
|
15
|
14
|
Baseline Characteristics
The analysis population was the All Randomized population.
Baseline characteristics by cohort
| Measure |
Roxadustat
n=415 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=421 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
Total
n=836 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 Years
STANDARD_DEVIATION 13.8 • n=5 Participants • The analysis population was the All Randomized population.
|
61.8 Years
STANDARD_DEVIATION 13.4 • n=7 Participants • The analysis population was the All Randomized population.
|
61.4 Years
STANDARD_DEVIATION 13.6 • n=5 Participants • The analysis population was the All Randomized population.
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
185 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
354 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Sex: Female, Male
Male
|
246 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
236 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
482 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Race/Ethnicity, Customized
WHITE
|
405 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
408 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
813 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
6 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
6 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
12 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Race/Ethnicity, Customized
ASIAN
|
2 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
3 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
5 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Race/Ethnicity, Customized
OTHER
|
2 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
4 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
6 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Baseline Hemoglobin (Hb) Value
<=11.0 g/dL
|
267 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
266 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
533 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Baseline Hemoglobin (Hb) Value
>11.0 g/dL
|
148 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
155 Participants
n=7 Participants • The analysis population was the All Randomized population.
|
303 Participants
n=5 Participants • The analysis population was the All Randomized population.
|
|
Baseline Mean Hb
|
10.75 g/dL
STANDARD_DEVIATION 0.62 • n=5 Participants • The analysis population was the All Randomized population.
|
10.77 g/dL
STANDARD_DEVIATION 0.62 • n=7 Participants • The analysis population was the All Randomized population.
|
10.76 g/dL
STANDARD_DEVIATION 0.62 • n=5 Participants • The analysis population was the All Randomized population.
|
PRIMARY outcome
Timeframe: Baseline and weeks 28 to 36Population: The analysis population was the Per Protocol Set (PPS) which consisted of all Full Analysis Set (FAS) participants who did not meet any of exclusion criteria from the PPS. The FAS consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose valid Hb assessment.
Baseline Hb was defined as the mean of four central laboratory Hb values; four latest Hb values prior or on the same date as the first study drug intake. For participants who did not have an available Hb value during the week 28-36 period, imputation rules were applied. For analyses without rescue therapy, participants who used rescue therapy after the initiation of rescue therapy were set to missing for 6 weeks from the start date of rescue therapy. If no Hb value was available, an imputation technique was used, with the mean of all available values from Day 1 to minimum (End of Efficacy Emergent Period) carried forward.
Outcome measures
| Measure |
Roxadustat
n=354 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=381 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)]
|
0.428 g/dL
Interval 0.35 to 0.506
|
0.193 g/dL
Interval 0.117 to 0.268
|
PRIMARY outcome
Timeframe: Baseline and weeks 28 to 52Population: The analysis population was the All Randomized, which consisted of participants who received at least one dose of study drug, and who had available data.
Baseline Hb was defined as the mean of four central laboratory Hb values: four latest Hb values prior or on the same date as first study drug intake. Change from baseline to the average Hb are observed values. Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model with treatment, baseline hemoglobin, randomization stratification factors and the available non missing hemoglobin for each scheduled week.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)]
|
0.363 g/dL
Interval 0.288 to 0.438
|
0.192 g/dL
Interval 0.121 to 0.262
|
SECONDARY outcome
Timeframe: Weeks 28 to 36Population: The analysis population was the PPS.
Hb response during weeks 28-36, was defined as mean Hb from 10-12 g/dL without receiving rescue therapy in the 6 weeks prior to, or during, the evaluation period. The percentages and 95% CI were unadjusted, the exact method of Clopper-Pearson was used for 95% CI. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to end of treatment (EOT) Visit or last non-missing Hb assessment (for participants who died during the treatment period).
Outcome measures
| Measure |
Roxadustat
n=386 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=397 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Percentage of Participants With Hb Response During Weeks 28 to 36
|
84.2 Percentage of participants
Interval 80.2 to 87.7
|
82.4 Percentage of participants
Interval 78.3 to 86.0
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the FAS, with participants who had available data.
Baseline LDL was defined as the LDL value on Day 1. If this value was missing, the latest value prior to first study drug administration was used.
Outcome measures
| Measure |
Roxadustat
n=394 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=412 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28
|
-0.459 mmol/L
Interval -0.517 to -0.401
|
-0.082 mmol/L
Interval -0.138 to -0.026
|
SECONDARY outcome
Timeframe: Day 1 to week 36Population: The analysis population was the FAS, with participants who had available data.
Participants with no or missing medication records of IV Iron have their monthly IV Iron use set to 0 mg. For participants who took IV Iron, but without a dosing frequency, the average values were set to missing.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=419 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Mean Monthly Intravenous (IV) Iron Use
|
21.6 mg per month
Interval 14.0 to 29.3
|
53.5 mg per month
Interval 46.0 to 61.1
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the PPS, with participants who had available data.
Baseline SF-36 PF was defined as the SF-36 PF value on Day 1.The SF-36 is a Quality of Life (QoL) instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measure eight scales: (1) physical functioning (PF); (2) role limitations due to physical health problems (RP); (3) bodily pain (BP); (4) social functioning (SF); (5) general health perceptions (GH); (6) role limitations due to emotional problems (RE); (7) vitality, energy or fatigue (VT); and (8) mental health(MH). Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consists of 11 questions focused on health and ability to do usual activities, with higher scores indicating better health status.
Outcome measures
| Measure |
Roxadustat
n=376 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=391 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28
|
0.050 Units on a scale
Interval -0.64 to 0.74
|
-0.155 Units on a scale
Interval -0.825 to 0.514
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the PPS, with participants who had available data.
Baseline VT Subscore was defined as the VT value on Day 1. The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 vitality has four questions with score range from 0-100 with higher scores indicating better vitality status.
Outcome measures
| Measure |
Roxadustat
n=377 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=391 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28
|
0.460 Units on a scale
Interval -0.329 to 1.249
|
-0.396 Units on a scale
Interval -1.165 to 0.373
|
SECONDARY outcome
Timeframe: Baseline and weeks 20 to 28Population: The analysis population was the PPS, with participants who had available data.
Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)\*DBP + (1/3)\*SBP.
Outcome measures
| Measure |
Roxadustat
n=373 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=388 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28
|
-0.969 mmHg
Interval -1.838 to -0.099
|
-0.120 mmHg
Interval -0.972 to 0.732
|
SECONDARY outcome
Timeframe: Weeks 1 to 36Population: The analysis population was the PPS, with participants who had available data.
Increase in Blood Pressure was defined as either: Systolic Blood Pressure (SBP) ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: Diastolic Blood Pressure (DBP) ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. For participants who have experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.
Outcome measures
| Measure |
Roxadustat
n=386 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=397 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Time to First Occurrence of an Increase in Blood Pressure
Week 12
|
11.7 Percentage of participants
Interval 8.5 to 14.9
|
11.1 Percentage of participants
Interval 8.0 to 14.2
|
|
Time to First Occurrence of an Increase in Blood Pressure
Week 24
|
15.9 Percentage of participants
Interval 12.2 to 19.6
|
15.4 Percentage of participants
Interval 11.9 to 19.0
|
|
Time to First Occurrence of an Increase in Blood Pressure
Week 36
|
21.1 Percentage of participants
Interval 14.0 to 28.2
|
23.5 Percentage of participants
Interval to 30.9
|
SECONDARY outcome
Timeframe: Baseline and weeks 20 to 28Population: The analysis population was the FAS, with participants who had available data.
Baseline MAP was defined as the MAP value on day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)\*DBP + (1/3)\*SBP.
Outcome measures
| Measure |
Roxadustat
n=381 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=401 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28
|
-0.739 mmHg
Interval -1.6 to 0.123
|
-0.160 mmHg
Interval -0.997 to 0.678
|
SECONDARY outcome
Timeframe: Weeks 1 to 36Population: The analysis population was the FAS, with participants who had available data.
Increase in Blood Pressure was defined as either: SBP ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: DBP ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Time to First Occurrence of an Increase in Blood Pressure
Week 12
|
11.6 Percentage of participants
Interval 8.5 to 14.8
|
12.0 Percentage of participants
Interval 8.9 to 15.1
|
|
Time to First Occurrence of an Increase in Blood Pressure
Week 24
|
16.1 Percentage of participants
Interval 12.5 to 19.7
|
16.2 Percentage of participants
Interval 12.6 to 19.7
|
|
Time to First Occurrence of an Increase in Blood Pressure
Week 36
|
21.2 Percentage of participants
Interval 14.1 to 28.3
|
24.1 Percentage of participants
Interval 16.7 to 31.4
|
SECONDARY outcome
Timeframe: Weeks 28 to 36Population: The analysis population was the FAS.
Hb response was defined as mean Hb during weeks 28 to 36 within the target range of 10.0 to 12.0 g/dL. The percentages and 95% CI are unadjusted, the exact method of Clopper-Pearson was used for 95% CI.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Percentage of Participants With a Hb Response During Weeks 28 and 36 Regardless of Use of Rescue Therapy
|
83.1 Percentage of participants
Interval 79.1 to 86.5
|
82.1 Percentage of participants
Interval 78.1 to 85.7
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, 18,20, 22, 24, 26, 28, 30, 32, 34, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72,76, 80, 84, 88, 92, 96, 100, and 104Population: The analysis population was the FAS.
Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose).
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 1
|
0.232 g/dL
Interval 0.164 to 0.3
|
0.068 g/dL
Interval 0.0 to 0.135
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 2
|
0.496 g/dL
Interval 0.42 to 0.572
|
0.054 g/dL
Interval -0.022 to 0.129
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 3
|
0.633 g/dL
Interval 0.552 to 0.714
|
0.071 g/dL
Interval -0.008 to 0.151
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 4
|
0.803 g/dL
Interval 0.715 to 0.891
|
0.095 g/dL
Interval 0.009 to 0.181
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 5
|
0.723 g/dL
Interval 0.633 to 0.812
|
-0.045 g/dL
Interval -0.133 to 0.043
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 6
|
0.868 g/dL
Interval 0.776 to 0.959
|
0.138 g/dL
Interval 0.048 to 0.228
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 7
|
0.698 g/dL
Interval 0.606 to 0.791
|
-0.031 g/dL
Interval -0.122 to 0.06
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 8
|
0.816 g/dL
Interval 0.724 to 0.907
|
0.116 g/dL
Interval 0.026 to 0.206
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 10
|
0.640 g/dL
Interval 0.546 to 0.735
|
-0.019 g/dL
Interval -0.111 to 0.073
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 12
|
0.732 g/dL
Interval 0.634 to 0.83
|
0.139 g/dL
Interval 0.043 to 0.235
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 14
|
0.508 g/dL
Interval 0.408 to 0.608
|
0.005 g/dL
Interval -0.093 to 0.103
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 16
|
0.613 g/dL
Interval 0.511 to 0.716
|
0.244 g/dL
Interval 0.144 to 0.344
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 18
|
0.380 g/dL
Interval 0.283 to 0.477
|
0.017 g/dL
Interval -0.078 to 0.112
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 20
|
0.501 g/dL
Interval 0.405 to 0.596
|
0.217 g/dL
Interval 0.124 to 0.309
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 22
|
0.266 g/dL
Interval 0.17 to 0.363
|
0.069 g/dL
Interval -0.025 to 0.163
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 24
|
0.262 g/dL
Interval 0.168 to 0.356
|
0.075 g/dL
Interval -0.017 to 0.166
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 26
|
0.316 g/dL
Interval 0.22 to 0.412
|
0.073 g/dL
Interval -0.02 to 0.165
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 28
|
0.549 g/dL
Interval 0.452 to 0.647
|
0.342 g/dL
Interval 0.248 to 0.437
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 30
|
0.333 g/dL
Interval 0.236 to 0.429
|
0.106 g/dL
Interval 0.013 to 0.198
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 32
|
0.310 g/dL
Interval 0.211 to 0.409
|
0.111 g/dL
Interval 0.016 to 0.207
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 34
|
0.364 g/dL
Interval 0.268 to 0.46
|
0.084 g/dL
Interval -0.007 to 0.176
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 36
|
0.482 g/dL
Interval 0.382 to 0.581
|
0.225 g/dL
Interval 0.13 to 0.32
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 40
|
0.199 g/dL
Interval 0.095 to 0.304
|
0.064 g/dL
Interval -0.036 to 0.163
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 44
|
0.335 g/dL
Interval 0.221 to 0.448
|
0.252 g/dL
Interval 0.145 to 0.36
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 48
|
0.158 g/dL
Interval 0.047 to 0.27
|
0.131 g/dL
Interval 0.027 to 0.236
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 52
|
0.385 g/dL
Interval 0.273 to 0.496
|
0.186 g/dL
Interval 0.082 to 0.29
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 56
|
0.217 g/dL
Interval 0.104 to 0.329
|
0.069 g/dL
Interval -0.035 to 0.174
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 60
|
0.368 g/dL
Interval 0.256 to 0.479
|
0.171 g/dL
Interval 0.067 to 0.275
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 64
|
0.181 g/dL
Interval 0.067 to 0.295
|
-0.093 g/dL
Interval -0.198 to 0.012
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 68
|
0.306 g/dL
Interval 0.195 to 0.416
|
0.100 g/dL
Interval -0.002 to 0.202
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 72
|
0.109 g/dL
Interval -0.005 to 0.222
|
-0.009 g/dL
Interval -0.113 to 0.095
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 76
|
0.401 g/dL
Interval 0.28 to 0.521
|
0.189 g/dL
Interval 0.079 to 0.299
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 80
|
0.087 g/dL
Interval -0.028 to 0.203
|
-0.015 g/dL
Interval -0.12 to 0.091
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 84
|
0.318 g/dL
Interval 0.199 to 0.438
|
0.126 g/dL
Interval 0.017 to 0.235
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 88
|
0.026 g/dL
Interval -0.091 to 0.144
|
-0.018 g/dL
Interval -0.124 to 0.088
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 92
|
0.357 g/dL
Interval 0.232 to 0.483
|
0.154 g/dL
Interval 0.041 to 0.267
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 96
|
0.126 g/dL
Interval 0.01 to 0.242
|
-0.058 g/dL
Interval -0.163 to 0.046
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 100
|
0.302 g/dL
Interval 0.175 to 0.43
|
0.138 g/dL
Interval 0.024 to 0.253
|
|
Change From BL in Hb to Each Postdosing Time Point
Hb Change From BL to Week 104
|
0.232 g/dL
Interval 0.1 to 0.363
|
0.133 g/dL
Interval 0.014 to 0.251
|
SECONDARY outcome
Timeframe: Weeks 28 to 36, 44 to 52, and 96 to 104Population: The analysis population was the FAS.
Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose). Averaged Hb values over weeks 28-36, weeks 44-52 and weeks 96-104 are observed values.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Average Hb Over Weeks 28-36
|
11.183 g/dL
Interval 11.1 to 11.265
|
10.946 g/dL
Interval 10.867 to 11.025
|
|
Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Average Hb Over Weeks 44-52
|
11.099 g/dL
Interval 11.009 to 11.189
|
10.994 g/dL
Interval 10.909 to 11.079
|
|
Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Average Hb Over Weeks 96-104
|
11.007 g/dL
Interval 10.904 to 11.11
|
10.858 g/dL
Interval 10.766 to 10.95
|
SECONDARY outcome
Timeframe: Baseline and weeks 28 to 36, 44 to 52, and 96 to 104Population: The analysis population was the FAS.
Change from baseline to the average Hb are observed values. Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose).
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy
Hb Change From BL to Weeks 28-36
|
0.408 g/dL
Interval 0.325 to 0.491
|
0.173 g/dL
Interval 0.093 to 0.252
|
|
Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy
Hb Change From BL to Weeks 44-52
|
0.298 g/dL
Interval 0.203 to 0.394
|
0.194 g/dL
Interval 0.104 to 0.284
|
|
Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy
Hb Change From BL to Weeks 96-104
|
0.225 g/dL
Interval 0.119 to 0.331
|
0.076 g/dL
Interval -0.02 to 0.171
|
SECONDARY outcome
Timeframe: Weeks 28-36, 44-52 and 96-104Population: The analysis population was the FAS.
Percentage for each participant was calculated as Number of Hb values \>= 10.0 g/dL / Total number of Hb values\*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Weeks 28-36
|
93.002 percentage of Hb values
Standard Deviation 18.320
|
87.286 percentage of Hb values
Standard Deviation 25.114
|
|
Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Weeks 44-52
|
89.421 percentage of Hb values
Standard Deviation 24.267
|
86.914 percentage of Hb values
Standard Deviation 25.366
|
|
Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Weeks 96-104
|
88.858 percentage of Hb values
Standard Deviation 24.708
|
83.543 percentage of Hb values
Standard Deviation 30.296
|
SECONDARY outcome
Timeframe: Weeks 28-36, 44-52 and 96-104Population: The analysis population was the FAS.
Percentage for each participant was calculated as Number of Hb values within 10.0-12.0 g/dL / Total number of Hb values\*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Weeks 28-36
|
76.326 percentage of Hb values
Standard Deviation 28.175
|
76.098 percentage of Hb values
Standard Deviation 28.991
|
|
Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Weeks 44-52
|
75.891 percentage of Hb values
Standard Deviation 31.047
|
74.634 percentage of Hb values
Standard Deviation 30.589
|
|
Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
Weeks 96-104
|
76.522 percentage of Hb values
Standard Deviation 30.378
|
73.690 percentage of Hb values
Standard Deviation 33.040
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (EOT) (Up to week 104)Population: The analysis population was the FAS, with participants who had available data.
The number of hospitalizations per participant were calculated during the Efficacy Emergent Period. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). It included all Non-Hemodialysis (HD) hospitalizations. The HD days were not counted as hospitalizations, even when performed overnight.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Number of Hospitalizations
|
0.9 Hospitalizations
Standard Deviation 1.3
|
0.9 Hospitalizations
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS, with participants who had available data.
The number of days of hospitalizations per year was calculated as the sum of the durations of all non-HD hospitalizations in days (Date of discharge - Date of admission + 1)\] / (duration of efficacy emergent period in days / 365.25). In case of missing dates, the hospitalization duration was imputed by the average duration per stay derived from the participants with non-missing duration within the same treatment group.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Number of Days of Hospitalization Per Year
|
12.186 Days per year
Standard Deviation 34.121
|
7.868 Days per year
Standard Deviation 22.948
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
Time to first hospitalization in years was defined in years as: (First event date during the Efficacy Emergent Period - Analysis date of First dose intake +1)/365.25, and the 'First event date' was defined as 'Date of first Admission and 'Analysis Date of first dose intake. For participants without hospitalization, the time to censoring was calculated as: (Date of End of Efficacy Emergent Period - Analysis Date of first dose intake + 1) / 365.25. Date of End of Efficacy Emergent Period was defined as as the treatment period up to the EOT visit. For participants who have experienced more than one hospitalization, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Time to First Hospitalization
Year 0.5
|
19.4 Percentage of participants
Interval 15.5 to 23.3
|
18.3 Percentage of participants
Interval 14.6 to 22.0
|
|
Time to First Hospitalization
Year 1
|
32.0 Percentage of participants
Interval 27.3 to 36.6
|
32.7 Percentage of participants
Interval 28.2 to 37.3
|
|
Time to First Hospitalization
Year 1.5
|
43.5 Percentage of participants
Interval 38.5 to 48.6
|
41.9 Percentage of participants
Interval 37.0 to 46.7
|
|
Time to First Hospitalization
Year 2
|
52.6 Percentage of participants
Interval 47.5 to 57.8
|
48.3 Percentage of participants
Interval 43.3 to 53.3
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
Rescue therapy was defined as red blood cell (RBC) transfusion for both treatment groups and ESA for roxadustat participants. Only rescue medication that was started during the study treatment and up to end of efficacy emergent period was taken into account and considered as use of rescue medication. For participants who have experienced more than one use of rescue therapy, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Time to First Use of Rescue Therapy
Year 0.5
|
3.9 Percentage of participants
Interval 2.0 to 5.8
|
3.2 Percentage of participants
Interval 1.5 to 4.8
|
|
Time to First Use of Rescue Therapy
Year 1
|
8.2 Percentage of participants
Interval 5.4 to 11.1
|
8.4 Percentage of participants
Interval 5.6 to 11.1
|
|
Time to First Use of Rescue Therapy
Year 1.5
|
11.4 Percentage of participants
Interval 8.1 to 14.8
|
10.9 Percentage of participants
Interval 7.8 to 14.0
|
|
Time to First Use of Rescue Therapy
Year 2
|
12.8 Percentage of participants
Interval 9.3 to 16.4
|
14.4 Percentage of participants
Interval 10.8 to 18.0
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
For participants who have experienced more than one RBC transfusion, only their first event following study treatment was used. For RBC transfusions, when the number of units was not given but the volume transfused was, the number of units were estimated by volume transfused/250 mL (for transfusion of packed cell units) or volume transfused/500 mL (for transfusion of full blood). Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Time to First RBC Transfusion
Year 0.5
|
3.6 Percentage of participants
Interval 1.8 to 5.5
|
3.2 Percentage of participants
Interval 1.5 to 4.8
|
|
Time to First RBC Transfusion
Year 1
|
7.4 Percentage of participants
Interval 4.7 to 10.1
|
8.4 Percentage of participants
Interval 5.6 to 11.1
|
|
Time to First RBC Transfusion
Year 1.5
|
10.0 Percentage of participants
Interval 6.9 to 13.2
|
10.9 Percentage of participants
Interval 7.8 to 14.0
|
|
Time to First RBC Transfusion
Year 2
|
11.4 Percentage of participants
Interval 8.0 to 14.9
|
14.4 Percentage of participants
Interval 10.8 to 18.0
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
During efficacy emergent period, the mean monthly number of RBC packs was calculated as the sum of blood volume and units transfused between the first dose and up to the last dose in the period divided by duration of efficacy emergent period (in days) divided by 28 days. Participants without medication records of RBC have their number of RBC packs and volume set to 0.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Mean Monthly Number of RBC Packs Per Participant
|
0.026 RBC packs per month
Interval 0.01 to 0.04
|
0.032 RBC packs per month
Interval 0.02 to 0.05
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
During Efficacy Emergent Period, the mean monthly volume of blood transfused was calculated as the sum of blood volume and units transfused between the first dose and up to the last dose in the period divided by duration of efficacy emergent period (in days) divided by 28 days. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period).
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Mean Monthly Volume of RBC Transfusion Per Participant
|
6.061 mL per month
Interval 2.82 to 9.3
|
5.929 mL per month
Interval 2.74 to 9.12
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
For participants who have received more than one IV iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Time to First Use of IV Iron Supplementation
Year 0.5
|
11.2 Percentage of participants
Interval 8.1 to 14.3
|
33.5 Percentage of participants
Interval 29.0 to 38.1
|
|
Time to First Use of IV Iron Supplementation
Year 1
|
17.4 Percentage of participants
Interval 13.5 to 21.2
|
44.1 Percentage of participants
Interval 39.3 to 49.0
|
|
Time to First Use of IV Iron Supplementation
Year 1.5
|
23.6 Percentage of participants
Interval 19.1 to 28.1
|
55.0 Percentage of participants
Interval 50.1 to 59.9
|
|
Time to First Use of IV Iron Supplementation
Year 2
|
33.3 Percentage of participants
Interval 26.0 to 40.7
|
59.3 Percentage of participants
Interval 54.4 to 64.3
|
SECONDARY outcome
Timeframe: Weeks 37-52 and weeks 53-104Population: The analysis population was the FAS.
Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Mean Monthly Intravenous (IV) Iron Per Participant During Weeks 37-52 and Weeks 53-104
Weeks 37-52
|
34.9 mg per month
Interval 20.9 to 48.9
|
70.0 mg per month
Interval 56.9 to 83.2
|
|
Mean Monthly Intravenous (IV) Iron Per Participant During Weeks 37-52 and Weeks 53-104
Weeks 53-104
|
49.5 mg per month
Interval 31.0 to 67.9
|
98.1 mg per month
Interval 81.1 to 115.2
|
SECONDARY outcome
Timeframe: Baseline to EOT (Up to week 104)Population: The analysis population was the FAS.
Percentage of participants with/without IV iron only was calculated based on total number of participants within the Efficacy Emergent Period. The Efficacy Emergent Period is defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period).
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Percentage of Participants With Oral Iron Use Only
|
31.0 Percentage of participants
|
11.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 28, 52, 104Population: The analysis population was the FAS.
Baseline assessment was the assessment from Day 1 visit. If baseline value was missing, then the latest screening period value was used as the baseline regardless of fasting status.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to Each Post-dosing Study Visit in Total Cholesterol
Change from BL to Week 8
|
-0.608 mmol/L
Standard Deviation 0.889
|
-0.105 mmol/L
Standard Deviation 0.712
|
|
Change From BL to Each Post-dosing Study Visit in Total Cholesterol
Change from BL to Week 28
|
-0.641 mmol/L
Standard Deviation 0.960
|
-0.135 mmol/L
Standard Deviation 0.805
|
|
Change From BL to Each Post-dosing Study Visit in Total Cholesterol
Change from BL to Week 52
|
-0.803 mmol/L
Standard Deviation 1.027
|
-0.241 mmol/L
Standard Deviation 0.906
|
|
Change From BL to Each Post-dosing Study Visit in Total Cholesterol
Change from BL to Week 104
|
-0.904 mmol/L
Standard Deviation 1.053
|
-0.277 mmol/L
Standard Deviation 1.002
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 28, 52, 104Population: The analysis population was the FAS.
Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio
Change from BL to Week 8
|
-0.245 Ratio
Standard Deviation 0.818
|
-0.060 Ratio
Standard Deviation 0.726
|
|
Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio
Change from BL to Week 28
|
-0.155 Ratio
Standard Deviation 1.046
|
-0.057 Ratio
Standard Deviation 0.922
|
|
Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio
Change from BL to Week 52
|
-0.345 Ratio
Standard Deviation 0.904
|
-0.078 Ratio
Standard Deviation 0.886
|
|
Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio
Change from BL to Week 104
|
-0.261 Ratio
Standard Deviation 1.167
|
-0.013 Ratio
Standard Deviation 1.048
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 28, 52, 104Population: The analysis population was the FAS.
Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol
Change from BL to Week 8
|
-0.518 mmol/L
Standard Deviation 0.823
|
-0.107 mmol/L
Standard Deviation 0.701
|
|
Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol
Change from BL to Week 28
|
-0.540 mmol/L
Standard Deviation 0.907
|
-0.127 mmol/L
Standard Deviation 0.789
|
|
Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol
Change from BL to Week 52
|
-0.700 mmol/L
Standard Deviation 0.965
|
-0.229 mmol/L
Standard Deviation 0.886
|
|
Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol
Change from BL to Week 104
|
-0.788 mmol/L
Standard Deviation 1.024
|
-0.240 mmol/L
Standard Deviation 1.010
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 28, 52, 104Population: The analysis population was the FAS.
Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)
Change from BL to Week 8
|
-0.114 g/L
Standard Deviation 0.197
|
-0.006 g/L
Standard Deviation 0.172
|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)
Change from BL to Week 28
|
-0.113 g/L
Standard Deviation 0.217
|
-0.012 g/L
Standard Deviation 0.193
|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)
Change from BL to Week 52
|
-0.097 g/L
Standard Deviation 0.230
|
-0.013 g/L
Standard Deviation 0.195
|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)
Change from BL to Week 104
|
-0.097 g/L
Standard Deviation 0.220
|
-0.012 g/L
Standard Deviation 0.196
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 28, 52, 104Population: The analysis population was the FAS.
Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)
Change from BL to Week 8
|
-11.03 mg/dL
Standard Deviation 18.49
|
1.00 mg/dL
Standard Deviation 14.34
|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)
Change from BL to Week 28
|
-11.18 mg/dL
Standard Deviation 20.39
|
-0.12 mg/dL
Standard Deviation 16.91
|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)
Change from BL to Week 52
|
-13.18 mg/dL
Standard Deviation 20.67
|
-0.01 mg/dL
Standard Deviation 18.88
|
|
Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)
Change from BL to Week 104
|
-13.50 mg/dL
Standard Deviation 24.94
|
-0.01 mg/dL
Standard Deviation 20.00
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 28, 52, 104Population: The analysis population was the FAS.
Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio
Change from BL to Week 8
|
-0.037 Ratio
Standard Deviation 0.147
|
0.013 Ratio
Standard Deviation 0.141
|
|
Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio
Change from BL to Week 28
|
-0.034 Ratio
Standard Deviation 0.177
|
0.002 Ratio
Standard Deviation 0.148
|
|
Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio
Change from BL to Week 52
|
-0.051 Ratio
Standard Deviation 0.191
|
0.007 Ratio
Standard Deviation 0.164
|
|
Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio
Change from BL to Week 104
|
-0.062 Ratio
Standard Deviation 0.210
|
0.007 Ratio
Standard Deviation 0.201
|
SECONDARY outcome
Timeframe: Weeks 12 to 28Population: The analysis population was the FAS.
Missing category for Fasting Only includes non-fasting participants and the participants with missing values.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
Missing [Fasting Only]
|
241 Number of participants
|
255 Number of participants
|
|
Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
Yes [Regardless of Fasting Status]
|
275 Number of participants
|
231 Number of participants
|
|
Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
No [Regardless of Fasting Status]
|
119 Number of participants
|
181 Number of participants
|
|
Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
Missing [Regardless of Fasting Status]
|
19 Number of participants
|
8 Number of participants
|
|
Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
Yes [Fasting Only]
|
111 Number of participants
|
85 Number of participants
|
|
Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
No [Fasting Only]
|
61 Number of participants
|
80 Number of participants
|
SECONDARY outcome
Timeframe: Weeks 12 to 28Population: The analysis population was the FAS.
Achieved antihypertensive treatment goal was defined as SBP \< 140 mmHg and DBP \< 90 mmHg over an evaluation period based on the average of available values in weeks 12-28 (pre-dialysis).
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal
Antihypertensive Treatment Achievement - Yes
|
264 Number of participants
|
261 Number of participants
|
|
Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal
Antihypertensive Treatment Achievement - No
|
130 Number of participants
|
149 Number of participants
|
|
Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal
Antihypertensive Treatment Achievement-Missing
|
19 Number of participants
|
10 Number of participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the FAS.
Baseline SF-36 PCS was defined as the SF-36 PCS value on Day 1. SF-36 contains 36-item that measures 8 scales with scores ranging from 0-100: physical functioning (PF); role limitations due to physical health problems (RP); bodily pain (BP); social functioning (SF); general health perceptions (GH); role limitations due to emotional problems (RE); vitality, energy or fatigue (VT); and mental health (MH). These scores are normed to the US population (norm-based scoring had very little impact on results when data was collected in Western European countries) to have a mean of 50 and standard deviation of 10. The PCS was calculated based on all 8 scales and ranges from 5.02-79.78. For each of these above scales, higher scores always indicating better health status.
Outcome measures
| Measure |
Roxadustat
n=384 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=404 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to the Average of Weeks 12 to 28 in SF-36 Physical Component Score (PCS)
|
0.560 Units on a scale
Interval -0.029 to 1.148
|
0.039 Units on a scale
Interval -0.528 to 0.605
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the FAS.
Baseline FACT-An AnS was defined as the FACT-An AnS value on Day 1. Together with the Functional Assessment of Cancer Therapy - General (FACT-G), the Anemia Subscale (AnS) is referred to as the FACT-An Total. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The Anemia AnS score range is 0 to 80. For the above score, a higher score indicates better QoL.
Outcome measures
| Measure |
Roxadustat
n=384 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=403 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to the Average of Weeks 12 to 28 in Anemia Subscale (AnS) ("Additional Concerns") of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score
|
0.400 Units on a scale
Interval -0.624 to 1.424
|
0.274 Units on a scale
Interval -0.709 to 1.257
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the FAS.
Baseline FACT-An Total Score was defined on Day 1. Total Fact-An score is composed of FACT-G and Ans scales. FACT-G contains 27 items that cover four dimensions of well-being: physical (PWB) - 7 items, functional (FWB) - 7 items, social/family (SWB) - 7 items, and emotional (EWB) - 6 items. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The total score is obtained by summation of the scores from PWB, SWB, EWB, FWB and AnS. The FACT-An Total Score scale range is 0-188. A higher score indicates better QoL.
Outcome measures
| Measure |
Roxadustat
n=383 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=403 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to the Average Value of Weeks 12 to 28 in Total FACT-An Score
|
-0.501 Units on a scale
Interval -2.581 to 1.58
|
-0.373 Units on a scale
Interval -2.367 to 1.622
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 to 28Population: The analysis population was the FAS.
Baseline assessment was defined as the value on Day 1. The EuroQol Questionnaire -5 Dimensions -5 Levels (EQ-5D-5L) is a self-reported questionnaire, used as a measure of respondents' Health Related Quality of Life (HRQoL) and utility values. The EQ-5D consists of the descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The VAS records the respondent's self rated health status on a graduated (0-100) scale, where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state' with higher scores for higher HRQoL.
Outcome measures
| Measure |
Roxadustat
n=385 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=401 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL to the Average of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score
|
3.041 Units on a scale
Standard Deviation 14.910
|
2.735 Units on a scale
Standard Deviation 14.477
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 12, 28, 36, 52, 76, 104Population: The analysis population was the FAS.
The PGIC is a patient-rated instrument that measures change in participant's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), when compared to the start of treatment. The percentage of participants presented includes very much improved, much improved and minimally improved.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 8
|
59.6 Percentage of participants
|
49.5 Percentage of participants
|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 12
|
65.5 Percentage of participants
|
49.5 Percentage of participants
|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 28
|
62.3 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 36
|
60.4 Percentage of participants
|
56.3 Percentage of participants
|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 52
|
57.1 Percentage of participants
|
55.3 Percentage of participants
|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 76
|
61.2 Percentage of participants
|
51.9 Percentage of participants
|
|
Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
Week 104
|
61.6 Percentage of participants
|
51.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 12, 20, 36, 52, 104, and End of Study (EOS - up to 108 weeks)Population: The analysis population was the FAS, with participants who had available data at baseline.
Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Serum Hepcidin
Week 4
|
-14.265 µg/L
Standard Deviation 42.393
|
-4.265 µg/L
Standard Deviation 33.518
|
|
Change From BL in Serum Hepcidin
Week 12
|
-12.298 µg/L
Standard Deviation 41.335
|
-6.741 µg/L
Standard Deviation 38.507
|
|
Change From BL in Serum Hepcidin
Week 20
|
-15.149 µg/L
Standard Deviation 43.152
|
-11.818 µg/L
Standard Deviation 41.596
|
|
Change From BL in Serum Hepcidin
Week 36
|
-23.405 µg/L
Standard Deviation 43.033
|
-14.530 µg/L
Standard Deviation 43.449
|
|
Change From BL in Serum Hepcidin
Week 52
|
-32.709 µg/L
Standard Deviation 42.342
|
-17.522 µg/L
Standard Deviation 47.307
|
|
Change From BL in Serum Hepcidin
Week 104
|
-40.101 µg/L
Standard Deviation 48.611
|
-18.735 µg/L
Standard Deviation 51.632
|
|
Change From BL in Serum Hepcidin
EOS
|
-27.192 µg/L
Standard Deviation 52.169
|
-17.664 µg/L
Standard Deviation 51.688
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, and EOS (up to 108 weeks)Population: The analysis population was the FAS.
Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Serum Ferritin
Week 4
|
-214.64 pmol/L
Standard Deviation 824.96
|
-141.78 pmol/L
Standard Deviation 456.15
|
|
Change From BL in Serum Ferritin
Week 8
|
-245.37 pmol/L
Standard Deviation 668.51
|
-160.75 pmol/L
Standard Deviation 607.39
|
|
Change From BL in Serum Ferritin
Week 12
|
-269.76 pmol/L
Standard Deviation 761.24
|
-179.47 pmol/L
Standard Deviation 586.95
|
|
Change From BL in Serum Ferritin
Week 20
|
-337.94 pmol/L
Standard Deviation 645.73
|
-246.89 pmol/L
Standard Deviation 727.64
|
|
Change From BL in Serum Ferritin
Week 28
|
-427.46 pmol/L
Standard Deviation 699.95
|
-265.21 pmol/L
Standard Deviation 816.64
|
|
Change From BL in Serum Ferritin
Week 36
|
-507.34 pmol/L
Standard Deviation 726.61
|
-269.26 pmol/L
Standard Deviation 855.01
|
|
Change From BL in Serum Ferritin
Week 44
|
-545.14 pmol/L
Standard Deviation 668.02
|
-323.30 pmol/L
Standard Deviation 986.38
|
|
Change From BL in Serum Ferritin
Week 52
|
-615.19 pmol/L
Standard Deviation 677.97
|
-347.58 pmol/L
Standard Deviation 1058.87
|
|
Change From BL in Serum Ferritin
Week 60
|
-622.55 pmol/L
Standard Deviation 675.22
|
-394.40 pmol/L
Standard Deviation 837.81
|
|
Change From BL in Serum Ferritin
Week 68
|
-604.47 pmol/L
Standard Deviation 773.19
|
-456.16 pmol/L
Standard Deviation 1039.18
|
|
Change From BL in Serum Ferritin
Week 76
|
-646.76 pmol/L
Standard Deviation 838.76
|
-447.70 pmol/L
Standard Deviation 967.63
|
|
Change From BL in Serum Ferritin
Week 84
|
-629.31 pmol/L
Standard Deviation 1060.24
|
-454.44 pmol/L
Standard Deviation 1193.43
|
|
Change From BL in Serum Ferritin
Week 92
|
-749.58 pmol/L
Standard Deviation 828.32
|
-371.64 pmol/L
Standard Deviation 1157.18
|
|
Change From BL in Serum Ferritin
Week 100
|
-746.86 pmol/L
Standard Deviation 796.74
|
-364.78 pmol/L
Standard Deviation 1802.37
|
|
Change From BL in Serum Ferritin
Week 104
|
-753.82 pmol/L
Standard Deviation 791.12
|
-348.70 pmol/L
Standard Deviation 1292.49
|
|
Change From BL in Serum Ferritin
EOS
|
-554.53 pmol/L
Standard Deviation 910.01
|
-166.94 pmol/L
Standard Deviation 2035.26
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and EOS (up to 108 weeks)Population: The analysis population was the FAS.
Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.
Outcome measures
| Measure |
Roxadustat
n=412 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Transferrin Saturation (TSAT)
Week 4
|
-4.151 Percentage of saturation
Standard Deviation 16.147
|
-2.331 Percentage of saturation
Standard Deviation 13.178
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 8
|
-3.681 Percentage of saturation
Standard Deviation 17.062
|
-3.128 Percentage of saturation
Standard Deviation 14.461
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 12
|
-2.643 Percentage of saturation
Standard Deviation 17.551
|
-3.189 Percentage of saturation
Standard Deviation 13.912
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 20
|
-3.782 Percentage of saturation
Standard Deviation 16.634
|
-4.398 Percentage of saturation
Standard Deviation 14.444
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 28
|
-5.463 Percentage of saturation
Standard Deviation 17.798
|
-3.829 Percentage of saturation
Standard Deviation 15.216
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 36
|
-5.351 Percentage of saturation
Standard Deviation 17.803
|
-4.022 Percentage of saturation
Standard Deviation 15.471
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 44
|
-6.069 Percentage of saturation
Standard Deviation 16.349
|
-5.254 Percentage of saturation
Standard Deviation 15.144
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 52
|
-7.278 Percentage of saturation
Standard Deviation 17.244
|
-5.788 Percentage of saturation
Standard Deviation 14.666
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 60
|
-6.997 Percentage of saturation
Standard Deviation 16.774
|
-5.187 Percentage of saturation
Standard Deviation 16.097
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 68
|
-7.279 Percentage of saturation
Standard Deviation 17.809
|
-6.237 Percentage of saturation
Standard Deviation 15.934
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 76
|
-7.156 Percentage of saturation
Standard Deviation 17.682
|
-6.623 Percentage of saturation
Standard Deviation 16.395
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 84
|
-7.867 Percentage of saturation
Standard Deviation 17.654
|
-5.378 Percentage of saturation
Standard Deviation 17.771
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 92
|
-6.996 Percentage of saturation
Standard Deviation 19.850
|
-6.259 Percentage of saturation
Standard Deviation 16.605
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 100
|
-8.379 Percentage of saturation
Standard Deviation 17.809
|
-6.354 Percentage of saturation
Standard Deviation 17.147
|
|
Change From BL in Transferrin Saturation (TSAT)
Week 104
|
-7.650 Percentage of saturation
Standard Deviation 17.842
|
-5.054 Percentage of saturation
Standard Deviation 17.195
|
|
Change From BL in Transferrin Saturation (TSAT)
EOS
|
-5.466 Percentage of saturation
Standard Deviation 16.626
|
-3.763 Percentage of saturation
Standard Deviation 17.813
|
SECONDARY outcome
Timeframe: Baseline and weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to 108 weeks)Population: The analysis population was the FAS, with participants who had available data at baseline.
Percentage of change from baseline to each study visit were calculated for HbA1c. Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.
Outcome measures
| Measure |
Roxadustat
n=413 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=419 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 12
|
0.0009 percentage of Glycated Hemoglobin
Standard Deviation 0.0071
|
-0.0005 percentage of Glycated Hemoglobin
Standard Deviation 0.0057
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 28
|
-0.0004 percentage of Glycated Hemoglobin
Standard Deviation 0.0067
|
-0.0006 percentage of Glycated Hemoglobin
Standard Deviation 0.0064
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 36
|
-0.0001 percentage of Glycated Hemoglobin
Standard Deviation 0.0065
|
-0.0004 percentage of Glycated Hemoglobin
Standard Deviation 0.0067
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 44
|
-0.0001 percentage of Glycated Hemoglobin
Standard Deviation 0.0069
|
-0.0006 percentage of Glycated Hemoglobin
Standard Deviation 0.0067
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 52
|
-0.0001 percentage of Glycated Hemoglobin
Standard Deviation 0.0070
|
-0.0007 percentage of Glycated Hemoglobin
Standard Deviation 0.0068
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 60
|
0.0000 percentage of Glycated Hemoglobin
Standard Deviation 0.0080
|
-0.0004 percentage of Glycated Hemoglobin
Standard Deviation 0.0070
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 84
|
0.0003 percentage of Glycated Hemoglobin
Standard Deviation 0.0072
|
0.0001 percentage of Glycated Hemoglobin
Standard Deviation 0.0078
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
Week 104
|
0.0000 percentage of Glycated Hemoglobin
Standard Deviation 0.0075
|
-0.0003 percentage of Glycated Hemoglobin
Standard Deviation 0.0082
|
|
Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
EOS
|
0.0011 percentage of Glycated Hemoglobin
Standard Deviation 0.0076
|
0.0001 percentage of Glycated Hemoglobin
Standard Deviation 0.0080
|
SECONDARY outcome
Timeframe: Baseline up to EOS (Up to week 108)Population: The analysis population was the Safety Analysis Set (SAF) which consisted of all randomized participants who received at least one dose of study drug.
Safety was assessed by evaluation of the following variables: (TEAEs; frequency, severity, seriousness, and relationship to study drug), Vital signs (systolic and diastolic blood pressure, pulse, respiratory rate and weight), Clinical laboratory variables (hematology, biochemistry including liver enzymes and total bilirubin, and urinalysis), Physical examination, 12-lead electrocardiogram (ECG) and Vascular Access Thrombosis. All AEs collected during the Safety Emergent Period were counted as TEAE. The TEAE was defined as an adverse event (AE) if it was observed after starting administration of the roxadustat or ESA. Any clinically significant abnormalities were reported as an AEs. All reported deaths after the first study drug administration and up to 28 days after the Analysis Date of Last Dose and considering last dosing frequency.
Outcome measures
| Measure |
Roxadustat
n=414 Participants
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 Participants
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE
|
359 Participants
|
361 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-Related TEAE
|
77 Participants
|
35 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAE
|
210 Participants
|
189 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-Related Serious TEAE
|
33 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE Leading to Death
|
67 Participants
|
55 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-Related TEAE Leading to Death
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE Leading to Withdrawal of Treatment
|
35 Participants
|
16 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-Related TEAE Leading to Withdraw of Treatment
|
9 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE NCI CTC Grades 3 or Higher
|
181 Participants
|
149 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Death During the Safety Emergent Period
|
64 Participants
|
51 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Death
|
78 Participants
|
59 Participants
|
Adverse Events
Roxadustat
Serious events: 210 serious events
Other events: 210 other events
Deaths: 78 deaths
ESA (Erythropoiesis-Stimulating Agent)
Serious events: 189 serious events
Other events: 209 other events
Deaths: 59 deaths
Serious adverse events
| Measure |
Roxadustat
n=414 participants at risk
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 participants at risk
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Wound
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
5/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.7%
7/420 • Number of events 8 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
9/414 • Number of events 9 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
2.6%
11/420 • Number of events 13 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
5/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.4%
6/420 • Number of events 8 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
12/414 • Number of events 14 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.9%
8/420 • Number of events 8 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Atrial flutter
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiac arrest
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.9%
8/420 • Number of events 9 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
8/414 • Number of events 8 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
2.1%
9/420 • Number of events 9 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiac failure acute
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
5/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiogenic shock
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Left ventricular failure
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.4%
6/420 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.97%
4/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Pericarditis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.2%
5/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Endocrine disorders
Hyperthyroidism
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Endocrine disorders
Toxic goitre
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Eye disorders
Cataract
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Eye disorders
Eye haemorrhage
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Anal fissure
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Anal fistula
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Diverticulum
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Faecaloma
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.4%
6/420 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Intestinal ulcer perforation
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Melaena
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Nausea
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.48%
2/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Vomiting
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Asthenia
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Catheter site inflammation
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Chest pain
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Chills
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Complication associated with device
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Death
|
1.4%
6/414 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Device related thrombosis
|
0.72%
3/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Hyperthermia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Impaired healing
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Malaise
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Medical device site phlebitis
|
0.24%
1/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Oedema peripheral
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Pain
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Peripheral swelling
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Pyrexia
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Sudden cardiac death
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Sudden death
|
1.7%
7/414 • Number of events 7 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Cholangitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Hepatobiliary disorders
Jaundice
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Immune system disorders
Renal transplant failure
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Abdominal infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Acute hepatitis B
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Appendicitis
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Arthritis bacterial
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Biliary sepsis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Bronchitis
|
1.2%
5/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Cellulitis
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Clostridium difficile infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Device related infection
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Device related sepsis
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Diabetic gangrene
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Diverticulitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Encephalomyelitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Endocarditis
|
0.48%
2/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Erysipelas
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.24%
1/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Fungal oesophagitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Gangrene
|
1.2%
5/414 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 7 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.4%
6/420 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Incision site infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Infected skin ulcer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Influenza
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Intervertebral discitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Liver abscess
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Localised infection
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Lung abscess
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Medical device site joint infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Osteomyelitis
|
0.24%
1/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pancreatitis bacterial
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Penile abscess
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Peritonitis
|
2.4%
10/414 • Number of events 15 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Peritonitis bacterial
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pneumonia
|
3.6%
15/414 • Number of events 15 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
5.0%
21/420 • Number of events 22 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Postoperative wound infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pyelonephritis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pyelonephritis acute
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Pyonephrosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Renal abscess
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Renal cyst infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Sepsis
|
1.9%
8/414 • Number of events 8 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
2.1%
9/420 • Number of events 9 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Sepsis syndrome
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Septic shock
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Skin infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Subcutaneous abscess
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Systemic infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Tracheobronchitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Urinary tract infection
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Urosepsis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.4%
6/414 • Number of events 7 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.2%
5/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.48%
2/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
7.0%
29/414 • Number of events 37 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
3.6%
15/420 • Number of events 18 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site stenosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.4%
6/420 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.2%
5/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.48%
2/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.24%
1/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Investigations
Blood potassium increased
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.48%
2/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.48%
2/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal neoplasm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney angiomyolipoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of choroid
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia with an excess of blasts
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.72%
3/414 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Cognitive disorder
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Coma
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Encephalopathy
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Epileptic encephalopathy
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.24%
1/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Idiopathic partial epilepsy
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Ischaemic stroke
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Loss of consciousness
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Seizure
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Syncope
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Product Issues
Device dislocation
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Product Issues
Device failure
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Product Issues
Device malfunction
|
0.97%
4/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Delirium
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Depression
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Fear of falling
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Psychiatric disorders
Organic brain syndrome
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Calculus urinary
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Haematuria
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Urethral perforation
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Renal and urinary disorders
Urinoma
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Reproductive system and breast disorders
Ovarian disorder
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
6/414 • Number of events 7 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
4/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
6/414 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Surgical and medical procedures
Catheter placement
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Surgical and medical procedures
Therapy cessation
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Aortic dissection
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Circulatory collapse
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
4/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Dry gangrene
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.48%
2/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Haematoma
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Haemorrhage
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Hypertension
|
2.4%
10/414 • Number of events 10 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.2%
5/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Hypertensive crisis
|
0.72%
3/414 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 8 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Hypotension
|
0.97%
4/414 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Lymphoedema
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Malignant hypertension
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Orthostatic hypotension
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 4 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.71%
3/420 • Number of events 3 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Peripheral ischaemia
|
0.48%
2/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.95%
4/420 • Number of events 6 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Steal syndrome
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.00%
0/420 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Thrombosis
|
0.24%
1/414 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Vasculitis necrotising
|
0.00%
0/414 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 2 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Venous stenosis
|
0.24%
1/414 • Number of events 1 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
0.24%
1/420 • Number of events 5 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
Other adverse events
| Measure |
Roxadustat
n=414 participants at risk
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
|
ESA (Erythropoiesis-Stimulating Agent)
n=420 participants at risk
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa.
|
|---|---|---|
|
Endocrine disorders
Hyperparathyroidism secondary
|
5.1%
21/414 • Number of events 21 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
3.8%
16/420 • Number of events 17 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
33/414 • Number of events 51 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
7.6%
32/420 • Number of events 60 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Gastrointestinal disorders
Nausea
|
6.5%
27/414 • Number of events 29 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
1.9%
8/420 • Number of events 10 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Bronchitis
|
7.0%
29/414 • Number of events 38 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
6.4%
27/420 • Number of events 34 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
14/414 • Number of events 19 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
5.0%
21/420 • Number of events 29 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.8%
28/414 • Number of events 61 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
9.3%
39/420 • Number of events 68 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
6.5%
27/414 • Number of events 34 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
4.3%
18/420 • Number of events 21 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
7.2%
30/414 • Number of events 39 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
12.1%
51/420 • Number of events 64 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
15/414 • Number of events 21 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
7.9%
33/420 • Number of events 48 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Nervous system disorders
Headache
|
8.7%
36/414 • Number of events 41 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
6.9%
29/420 • Number of events 39 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Hypertension
|
15.9%
66/414 • Number of events 101 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
17.9%
75/420 • Number of events 116 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
|
Vascular disorders
Hypotension
|
7.2%
30/414 • Number of events 40 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
6.2%
26/420 • Number of events 40 • From first dose of study drug up to End of Study (EOS) (Up to week 108)
The Safety Emergent Period was defined as the evaluation period from the Analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER