Trial Outcomes & Findings for Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2) (NCT NCT01322347)
NCT ID: NCT01322347
Last Updated: 2017-04-26
Results Overview
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
294 participants
Primary outcome timeframe
Hgb measured weekly; up to 48 weeks from date of randomization
Results posted on
2017-04-26
Participant Flow
Participant milestones
| Measure |
Soluble Ferric Pyrophosphate (SFP) in Dialysate
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Standard Dialysate (Placebo)
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
147
|
|
Overall Study
Completed 48 Wks in St 2
|
28
|
22
|
|
Overall Study
Comp St 2 Due to ESA/IV Iron Needs
|
68
|
90
|
|
Overall Study
Enrolled in St 3
|
101
|
113
|
|
Overall Study
Completed St 3
|
82
|
86
|
|
Overall Study
COMPLETED
|
96
|
112
|
|
Overall Study
NOT COMPLETED
|
51
|
35
|
Reasons for withdrawal
| Measure |
Soluble Ferric Pyrophosphate (SFP) in Dialysate
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Standard Dialysate (Placebo)
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
non-protocol change to ESA or IV iron
|
14
|
6
|
|
Overall Study
blood transfusion
|
5
|
5
|
|
Overall Study
sponsor decision
|
1
|
3
|
|
Overall Study
ineligible
|
6
|
3
|
|
Overall Study
kidney transplant
|
3
|
1
|
|
Overall Study
study drug withheld > 12 wks
|
0
|
1
|
|
Overall Study
moved/changed dialysis
|
2
|
4
|
Baseline Characteristics
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
Baseline characteristics by cohort
| Measure |
Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=147 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Standard Dialysate (Placebo)
n=147 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 14.38 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 13.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=5 Participants
|
123 participants
n=7 Participants
|
251 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
24 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Height
|
168.80 centimeters
STANDARD_DEVIATION 10.238 • n=5 Participants
|
170.01 centimeters
STANDARD_DEVIATION 9.944 • n=7 Participants
|
169.40 centimeters
STANDARD_DEVIATION 10.093 • n=5 Participants
|
|
Post-dialysis weight
|
86.64 kilograms
STANDARD_DEVIATION 22.270 • n=5 Participants
|
85.09 kilograms
STANDARD_DEVIATION 23.474 • n=7 Participants
|
85.86 kilograms
STANDARD_DEVIATION 22.857 • n=5 Participants
|
PRIMARY outcome
Timeframe: Hgb measured weekly; up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean
|
-0.5 grams per liter
Standard Error 1.08
|
-4.0 grams per liter
Standard Error 1.09
|
PRIMARY outcome
Timeframe: Hgb measured weekly; up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin
Baseline Hemoglobin
|
109.6 grams per liter
Standard Deviation 6.09
|
109.3 grams per liter
Standard Deviation 6.25
|
|
Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin
End-of-Treatment Hemoglobin
|
108.7 grams per liter
Standard Deviation 13.81
|
104.9 grams per liter
Standard Deviation 13.33
|
|
Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin
Mean Change in Hemoglobin from at End-of-
|
-0.9 grams per liter
Standard Deviation 11.76
|
-4.5 grams per liter
Standard Deviation 11.71
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.
The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis
mean post-dialysis serum iron
|
31.347 micromoles per liter
Standard Deviation 7.9885
|
12.247 micromoles per liter
Standard Deviation 4.0720
|
|
Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis
serum iron change from pre- to post-dialysis
|
19.675 micromoles per liter
Standard Deviation 6.8227
|
1.194 micromoles per liter
Standard Deviation 3.4709
|
|
Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis
mean pre-dialysis serum iron
|
11.634 micromoles per liter
Standard Deviation 3.2506
|
11.086 micromoles per liter
Standard Deviation 3.0143
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.
The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis
mean pre-dialysis TSAT (transferrin)
|
24.7 percent
Standard Deviation 6.67
|
23.2 percent
Standard Deviation 8.35
|
|
Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis
mean post-dialysis TSAT (transferrin)
|
62.3 percent
Standard Deviation 13.32
|
23.3 percent
Standard Deviation 7.80
|
|
Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis
pre- to post-dialysis change in TSAT
|
37.5 percent
Standard Deviation 11.46
|
0.1 percent
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.
The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis
pre- to post-dialysis change in UIBC
|
-13.31 micromole per liter
Standard Deviation 5.024
|
2.57 micromole per liter
Standard Deviation 3.345
|
|
Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis
mean pre-dialysis UIBC
|
30.54 micromole per liter
Standard Deviation 5.645
|
32.19 micromole per liter
Standard Deviation 6.847
|
|
Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis
mean post-dialysis UIBC
|
17.15 micromole per liter
Standard Deviation 6.030
|
34.75 micromole per liter
Standard Deviation 7.437
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: intent-to-treat: all randomized subjects
The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=147 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=147 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion
|
6 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: intent-to-treat: all randomized subjects
The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=147 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=147 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused
|
15 units of red blood cells or whole blood
|
29 units of red blood cells or whole blood
|
SECONDARY outcome
Timeframe: up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.
A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
CHr percentage of change from baseline
|
-1.62 percentage of change from baseline
Standard Deviation 4.402
|
-2.59 percentage of change from baseline
Standard Deviation 4.490
|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
Ferritin percentage of change from baseline
|
-11.6 percentage of change from baseline
Standard Deviation 29.51
|
-21.7 percentage of change from baseline
Standard Deviation 68.50
|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
Serum Iron percentage of change from baseline
|
2.470 percentage of change from baseline
Standard Deviation 31.3742
|
-7.313 percentage of change from baseline
Standard Deviation 27.8687
|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
TIBC percentage of change from baseline
|
1.87 percentage of change from baseline
Standard Deviation 9.472
|
3.48 percentage of change from baseline
Standard Deviation 10.166
|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
TSAT percentage of change from baseline
|
0.6 percentage of change from baseline
Standard Deviation 29.69
|
-10.5 percentage of change from baseline
Standard Deviation 25.06
|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
UIBC percentage of change from baseline
|
3.77 percentage of change from baseline
Standard Deviation 14.717
|
9.46 percentage of change from baseline
Standard Deviation 16.537
|
|
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
Transferrin percentage of change from baseline
|
1.318 percentage of change from baseline
Standard Deviation 9.3574
|
3.988 percentage of change from baseline
Standard Deviation 10.6940
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
TIBC Change from Baseline to EoT
|
0.67 micromoles per liter
Standard Deviation 0.093
|
1.22 micromoles per liter
Standard Deviation 4.466
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
Baseline UIBC
|
30.17 micromoles per liter
Standard Deviation 5.866
|
30.70 micromoles per liter
Standard Deviation 6.481
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
EoT UIBC
|
31.03 micromoles per liter
Standard Deviation 6.501
|
33.24 micromoles per liter
Standard Deviation 7.115
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
UIBC Change from Baseline to EoT
|
0.92 micromoles per liter
Standard Deviation 4.359
|
2.56 micromoles per liter
Standard Deviation 4.653
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
Baseline Serum Iron
|
11.663 micromoles per liter
Standard Deviation 3.7879
|
11.949 micromoles per liter
Standard Deviation 3.9547
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
EoT Serum Iron
|
11.438 micromoles per liter
Standard Deviation 3.5804
|
10.658 micromoles per liter
Standard Deviation 3.3615
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
Serum Iron Change from Baseline to EoT
|
-0.244 micromoles per liter
Standard Deviation 3.4146
|
-1.342 micromoles per liter
Standard Deviation 3.3957
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
Baseline TIBC
|
41.83 micromoles per liter
Standard Deviation 6.184
|
42.65 micromoles per liter
Standard Deviation 6.942
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
EoT TIBC
|
42.47 micromoles per liter
Standard Deviation 6.866
|
43.90 micromoles per liter
Standard Deviation 6.928
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
Baseline CHr
|
32.57 picograms
Standard Deviation 2.239
|
32.54 picograms
Standard Deviation 1.928
|
|
Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
EoT CHr
|
32.01 picograms
Standard Deviation 2.140
|
31.69 picograms
Standard Deviation 2.130
|
|
Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
CHr Change from Baseline to EoT
|
-0.56 picograms
Standard Deviation 0.021
|
-0.86 picograms
Standard Deviation 1.480
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to End-of-Treatment (EoT) in Ferritin
Baseline Ferritin
|
513.6 micrograms per liter
Standard Deviation 201.37
|
479.8 micrograms per liter
Standard Deviation 201.52
|
|
Change From Baseline to End-of-Treatment (EoT) in Ferritin
EoT Ferritin
|
446.5 micrograms per liter
Standard Deviation 225.33
|
359.3 micrograms per liter
Standard Deviation 278.61
|
|
Change From Baseline to End-of-Treatment (EoT) in Ferritin
Ferritin Change from Baseline to EoT
|
-67.1 micrograms per liter
Standard Deviation 164.39
|
-122.7 micrograms per liter
Standard Deviation 269.70
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
EoT Transferrin
|
1.902 grams per liter
Standard Deviation 0.3267
|
1.987 grams per liter
Standard Deviation 0.3366
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
Baseline Transferrin
|
1.885 grams per liter
Standard Deviation 0.3049
|
1.921 grams per liter
Standard Deviation 0.3224
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
Transferrin Change from Baseline to EoT
|
0.019 grams per liter
Standard Deviation 0.1839
|
0.066 grams per liter
Standard Deviation 0.2138
|
SECONDARY outcome
Timeframe: Up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
Baseline TSAT
|
27.9 percentage
Standard Deviation 8.25
|
28.2 percentage
Standard Deviation 8.58
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
EoT TSAT
|
27.1 percentage
Standard Deviation 8.01
|
24.6 percentage
Standard Deviation 8.42
|
|
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
TSAT Change from Baseline to EoT
|
-0.9 percentage
Standard Deviation 7.65
|
-3.7 percentage
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.
The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Variability of Hemoglobin Concentration: Temporal Trend
|
0.023 grams per liter per week
Standard Deviation 0.222
|
0.003 grams per liter per week
Standard Deviation 0.350
|
SECONDARY outcome
Timeframe: up to 48 weeks from date of randomizationPopulation: modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.
The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.
Outcome measures
| Measure |
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=142 Participants
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.
|
Stage 2 Placebo (Standard Dialysate)
n=144 Participants
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.
|
|---|---|---|
|
Variability of Hemoglobin Concentration: Residual Standard Deviation
|
4.352 grams per liter
Standard Deviation 1.501
|
4.407 grams per liter
Standard Deviation 2.031
|
Adverse Events
Stage 2 Standard Dialysate (Placebo)
Serious events: 36 serious events
Other events: 93 other events
Deaths: 0 deaths
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
Serious events: 44 serious events
Other events: 89 other events
Deaths: 0 deaths
Stage 3 Soluble Ferric Pyrophosphate (SFP)
Serious events: 83 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 2 Standard Dialysate (Placebo)
n=145 participants at risk
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.
|
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=143 participants at risk
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.
|
Stage 3 Soluble Ferric Pyrophosphate (SFP)
n=214 participants at risk
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
VERTEBROBASILAR INSUFFICIENCY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
VOMITING
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.1%
3/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
3/214 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
3/214 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.4%
2/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
AORTIC DISSECTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
AORTIC STENOSIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA SITE COMPLICATION
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
HYPERVOLAEMIA
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
ARTERIOVENOUS FISTULA SITE INFECTION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA THROMBOSIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS GRAFT SITE HAEMORRHAGE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
ARTERIOVENOUS GRAFT SITE INFECTION
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
BRONCHITIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Surgical and medical procedures
CARDIAC ABLATION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.4%
2/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARDIAC NEOPLASM UNSPECIFIED
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
CHEST PAIN
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Congenital, familial and genetic disorders
CONGENITAL CYSTIC KIDNEY DISEASE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
3/214 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
DEATH
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
3/214 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
DIABETIC FOOT
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
DIABETIC FOOT INFECTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
DIABETIC GASTROPARESIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
3/214 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
EXSANGUINATION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
FALL
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
2.1%
3/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.7%
10/214 • Number of events 12 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
FRACTURE DISPLACEMENT
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
GANGRENE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.3%
5/214 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 9 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Endocrine disorders
HYPERPARATHYROIDISM SECONDARY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
HYPERTENSIVE EMERGENCY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
HYPOTENSION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
INFLUENZA
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
INGUINAL HERNIA, OBSTRUCTIVE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
JOINT ABSCESS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
MALAISE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
MALIGNANT HYPERTENSION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
NEUROGLYCOPENIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
6/214 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Surgical and medical procedures
OBESITY SURGERY
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
3/214 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
PALPITATIONS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
PANCREATITIS CHRONIC
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
PANCREATITIS RELAPSING
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
PNEUMONIA
|
2.1%
3/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
PSEUDOMONAL BACTERAEMIA
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
PYREXIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Renal and urinary disorders
RENAL CYST HAEMORRHAGE
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Surgical and medical procedures
REVERSAL OF ILEOJEJUNAL BYPASS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
SEPSIS SYNDROME
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
SUDDEN DEATH
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
SYNCOPE
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
TEMPORAL ARTERITIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTIS CANCER
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Investigations
TROPONIN INCREASED
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.93%
2/214 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT COMPLICATION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.47%
1/214 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT THROMBOSIS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/214 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
Other adverse events
| Measure |
Stage 2 Standard Dialysate (Placebo)
n=145 participants at risk
0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.
|
Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate
n=143 participants at risk
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.
|
Stage 3 Soluble Ferric Pyrophosphate (SFP)
n=214 participants at risk
11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3).
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.4%
5/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.2%
9/214 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.8%
4/145 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.4%
5/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.9%
17/214 • Number of events 21 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.4%
2/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.1%
11/214 • Number of events 13 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Psychiatric disorders
ANXIETY
|
2.1%
3/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA SITE COMPLICATION
|
9.7%
14/145 • Number of events 21 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
10.5%
15/143 • Number of events 19 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
24.3%
52/214 • Number of events 85 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE
|
1.4%
2/145 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.2%
6/143 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.6%
12/214 • Number of events 18 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.4%
5/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
6.5%
14/214 • Number of events 16 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
ASTHENIA
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.9%
17/214 • Number of events 20 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.1%
6/145 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.2%
6/143 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.9%
17/214 • Number of events 20 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
BRADYCARDIA
|
2.8%
4/145 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 15 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
BRONCHITIS
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
CELLULITIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
CHILLS
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 13 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
8.4%
18/214 • Number of events 19 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
4.1%
6/145 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.2%
6/143 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.2%
9/214 • Number of events 12 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.7%
14/145 • Number of events 15 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.0%
10/143 • Number of events 13 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
8.4%
18/214 • Number of events 23 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.3%
12/145 • Number of events 14 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.0%
10/143 • Number of events 12 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
16.4%
35/214 • Number of events 62 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
DIZZINESS
|
5.5%
8/145 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
6.3%
9/143 • Number of events 19 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
15.9%
34/214 • Number of events 45 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.1%
3/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
6/214 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
4.1%
6/145 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.7%
11/143 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
13.1%
28/214 • Number of events 36 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.69%
1/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
FACE OEDEMA
|
2.1%
3/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.6%
12/214 • Number of events 15 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 9 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
FATIGUE
|
2.8%
4/145 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
6.5%
14/214 • Number of events 15 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
4.8%
7/145 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
8.9%
19/214 • Number of events 45 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
HAEMODIALYSIS-INDUCED SYMPTOM
|
6.2%
9/145 • Number of events 19 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.0%
10/143 • Number of events 14 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
27.1%
58/214 • Number of events 183 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Nervous system disorders
HEADACHE
|
5.5%
8/145 • Number of events 9 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
9.1%
13/143 • Number of events 23 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
18.7%
40/214 • Number of events 61 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
2.1%
3/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
9.8%
21/214 • Number of events 21 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
HYPERTENSION
|
3.4%
5/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
2.8%
4/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Vascular disorders
HYPOTENSION
|
2.8%
4/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.7%
10/214 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Psychiatric disorders
INSOMNIA
|
3.4%
5/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
3.4%
5/145 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.6%
8/143 • Number of events 9 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.9%
4/214 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.4%
2/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 9 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
9/145 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.1%
11/214 • Number of events 12 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
NAUSEA
|
10.3%
15/145 • Number of events 19 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.7%
11/143 • Number of events 21 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
21.5%
46/214 • Number of events 74 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
2.8%
4/145 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.2%
9/214 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
OEDEMA PERIPHERAL
|
2.1%
3/145 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
8.4%
12/143 • Number of events 14 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
14.5%
31/214 • Number of events 49 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
PAIN
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
9.3%
20/214 • Number of events 26 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.2%
9/145 • Number of events 12 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.9%
7/143 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
11.2%
24/214 • Number of events 28 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL DIZZINESS
|
1.4%
2/145 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
4/143 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 20 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HEADACHE
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 14 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPERTENSION
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.6%
12/214 • Number of events 26 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
11.0%
16/145 • Number of events 67 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
13.3%
19/143 • Number of events 143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
35.0%
75/214 • Number of events 567 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
1.4%
2/145 • Number of events 4 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
6.1%
13/214 • Number of events 18 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.69%
1/145 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.9%
17/214 • Number of events 20 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
4.7%
10/214 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
PYREXIA
|
3.4%
5/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
9.8%
21/214 • Number of events 23 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Cardiac disorders
TACHYCARDIA
|
2.8%
4/145 • Number of events 5 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.70%
1/143 • Number of events 14 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
General disorders
THROMBOSIS IN DEVICE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 2 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.7%
8/214 • Number of events 14 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/145 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.1%
3/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 10 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.5%
8/145 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.6%
8/143 • Number of events 11 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.6%
12/214 • Number of events 16 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.5%
5/143 • Number of events 7 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
2.8%
6/214 • Number of events 6 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT COMPLICATION
|
2.8%
4/145 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
1.4%
2/143 • Number of events 3 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
5.1%
11/214 • Number of events 13 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT THROMBOSIS
|
0.69%
1/145 • Number of events 1 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
0.00%
0/143 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
3.3%
7/214 • Number of events 8 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
|
Gastrointestinal disorders
VOMITING
|
8.3%
12/145 • Number of events 16 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
7.7%
11/143 • Number of events 15 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
15.4%
33/214 • Number of events 46 • In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
|
Additional Information
Senior Director, Clinical Research & Development
Rockwell Medical
Phone: 248-960-9009
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60