Trial Outcomes & Findings for Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice (NCT NCT01134315)
NCT ID: NCT01134315
Last Updated: 2013-08-13
Results Overview
Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.
Recruitment status
TERMINATED
Target enrollment
61 participants
Primary outcome timeframe
Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Results posted on
2013-08-13
Participant Flow
Participant milestones
| Measure |
Paricalcitol
Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
40
|
|
Overall Study
COMPLETED
|
12
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
19
|
Reasons for withdrawal
| Measure |
Paricalcitol
Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Other Reason
|
8
|
17
|
Baseline Characteristics
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
Baseline characteristics by cohort
| Measure |
Paricalcitol
n=21 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=40 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<8 years
|
5 participants
n=5 Participants
|
19 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Age, Customized
>=8 years
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
40 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Monitored from time of informed consent through end of study + 30 days (total of 745 days).Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]).
Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.
Outcome measures
| Measure |
Paricalcitol
n=19 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=37 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Percentage of Participants With at Least One Incidence of Hypercalcemia
Overall population (n=19, 37)
|
36.8 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants With at Least One Incidence of Hypercalcemia
Participants <3 months in study (n=2, 5)
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least One Incidence of Hypercalcemia
Participants >=3 months in study (n=17, 32)
|
35.3 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Monitored from time of informed consent through end of study + 30 days (total of 745 days).Population: All participants
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.
Outcome measures
| Measure |
Paricalcitol
n=21 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=40 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Any AE
|
17 participants
|
32 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Any severe AE
|
3 participants
|
12 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Any SAE
|
8 participants
|
26 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Any AE leading to discontinuation of study drug
|
1 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Any AE leading to discontinuation of study
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Any fatal AE
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Deaths (includes non-treatment-emergent deaths)
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]); n=number of participants with measurements at baseline and given time point.
Normal ranges for these chemistry measurements varied according to the age of the participant.
Outcome measures
| Measure |
Paricalcitol
n=19 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=37 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Potassium, BL (n=15, 29)
|
4.4 mEq/L
Standard Deviation 0.70
|
4.4 mEq/L
Standard Deviation 0.83
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Potassium, change from BL at FV (n=15, 29)
|
-0.1 mEq/L
Standard Deviation 0.81
|
-0.5 mEq/L
Standard Deviation 1.00
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Sodium, BL (n=15, 29)
|
138.0 mEq/L
Standard Deviation 2.75
|
139.3 mEq/L
Standard Deviation 4.42
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Sodium, change from BL at FV (n=15, 29)
|
0.2 mEq/L
Standard Deviation 2.96
|
-0.7 mEq/L
Standard Deviation 3.43
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Chloride, BL (n=15, 29)
|
99.5 mEq/L
Standard Deviation 4.75
|
98.6 mEq/L
Standard Deviation 3.78
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Chloride, change from BL at FV (n=15, 29)
|
-0.5 mEq/L
Standard Deviation 4.52
|
-1.1 mEq/L
Standard Deviation 4.07
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Bicarbonate, BL (n=15, 28)
|
26.1 mEq/L
Standard Deviation 2.76
|
25.9 mEq/L
Standard Deviation 4.12
|
|
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Bicarbonate, change from BL at FV (n=15, 28)
|
0.2 mEq/L
Standard Deviation 3.63
|
0.1 mEq/L
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]); n=number of participants with measurements at baseline and given time point.
Normal ranges for these chemistry measurements varied according to the age of the participant.
Outcome measures
| Measure |
Paricalcitol
n=19 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=37 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Calcium, BL (n=15, 30)
|
9.2 mg/dL
Standard Deviation 0.84
|
9.3 mg/dL
Standard Deviation 1.10
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Calcium, change from BL at FV (n=15, 30)
|
0.0 mg/dL
Standard Deviation 0.77
|
0.5 mg/dL
Standard Deviation 1.22
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Inorganic Phosphate (IP), BL (n=13, 29)
|
5.8 mg/dL
Standard Deviation 1.74
|
5.9 mg/dL
Standard Deviation 1.71
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
IP, change from BL at FV (n=13, 29)
|
-0.4 mg/dL
Standard Deviation 1.55
|
0.4 mg/dL
Standard Deviation 1.89
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
BUN, BL (n=15, 29)
|
52.7 mg/dL
Standard Deviation 24.43
|
49.8 mg/dL
Standard Deviation 18.69
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
BUN, change from BL at FV (n=15, 29)
|
-10.7 mg/dL
Standard Deviation 23.18
|
-1.9 mg/dL
Standard Deviation 19.05
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Creatinine, BL (n=15, 29)
|
9.4 mg/dL
Standard Deviation 4.35
|
8.8 mg/dL
Standard Deviation 4.35
|
|
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Creatinine, change from BL at FV (n=15, 29)
|
0.3 mg/dL
Standard Deviation 1.98
|
0.3 mg/dL
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
Normal ranges for these chemistry measurements varied according to the age of the participant.
Outcome measures
| Measure |
Paricalcitol
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=2 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)
Baseline
|
—
|
28.4 ng/mL
Standard Deviation 6.51
|
|
Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)
Change from Baseline at FV
|
—
|
7.5 ng/mL
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
Normal ranges for these chemistry measurements varied according to the age of the participant.
Outcome measures
| Measure |
Paricalcitol
n=1 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)
Baseline
|
20.0 pg/mL
Standard Deviation NA
Only 1 participant analyzed.
|
—
|
|
Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)
Change from Baseline at FV
|
-10.0 pg/mL
Standard Deviation NA
Only 1 participant analyzed.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
Normal ranges for these chemistry measurements varied according to the age of the participant.
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=21 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)
Baseline
|
571.7 pg/mL
Standard Deviation 532.52
|
592.8 pg/mL
Standard Deviation 619.72
|
|
Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)
Change from Baseline at FV
|
-102.5 pg/mL
Standard Deviation 695.39
|
-193.4 pg/mL
Standard Deviation 489.11
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
Normal ranges for these chemistry measurements varied according to the age of the participant.
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=29 Participants
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)
Baseline
|
3.3 g/dL
Standard Deviation 0.77
|
3.8 g/dL
Standard Deviation 0.52
|
|
Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)
Change from Baseline at FV
|
-0.0 g/dL
Standard Deviation 0.54
|
-0.1 g/dL
Standard Deviation 0.69
|
Adverse Events
Paricalcitol
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Calcitriol
Serious events: 26 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paricalcitol
n=21 participants at risk
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=40 participants at risk
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Endocrine disorders
Adrenocortical Insufficiency Acute
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Umbilical Hernia, Obstructive
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Catheter Site Erosion
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Device Dislocation
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Device Leakage
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Device Malfunction
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Medical Device Complication
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
7.5%
3/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Catheter Site Cellulitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Fungal Peritonitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Meningitis Aseptic
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Peritonitis
|
19.0%
4/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
20.0%
8/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Peritonitis Bacterial
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Septic Shock
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Injury, poisoning and procedural complications
Peritoneal Dialysis Complication
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Urea Nitrogen/Creatinine Ratio Increased
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Weight Decreased
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Renal Osteodystrophy
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Cerebral Infarction
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Convulsion
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Seizure Anoxic
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Psychiatric disorders
Eating Disorder
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Vascular disorders
Wegener's Granulomatosis
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
Other adverse events
| Measure |
Paricalcitol
n=21 participants at risk
Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
|
Calcitriol
n=40 participants at risk
Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Eye disorders
Visual Impairment
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Abdominal Mass
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
10.0%
4/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Bloody Peritoneal Effluent
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
10.0%
4/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
12.5%
5/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
12.5%
5/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Pancreatitis
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
10.0%
4/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Asthenia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Catheter Site Discharge
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Catheter Site Erythema
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Catheter Site Haemorrhage
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Catheter Site Pain
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Catheter Site Related Reaction
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Device Damage
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Device Malfunction
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Fatigue
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Oedema Peripheral
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Pain
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
10.0%
4/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Immune system disorders
Seasonal Allergy
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Candida Nappy Rash
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Catheter Site Infection
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
7.5%
3/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Cellulitis
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Chronic Sinusitis
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Device Related Infection
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Ear Infection
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
7.5%
3/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Gastroenteritis
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Graft Infection
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Otitis Media
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Peritonitis
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
7.5%
3/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
14.3%
3/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Serratia Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Stitch Abscess
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
14.3%
3/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
12.5%
5/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Infections and infestations
Wound Infection
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haemorrhage
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Injury, poisoning and procedural complications
Feeding Tube Complication
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Cortisol Increased
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Phosphorus Increased
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Haemoglobin Decreased
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Heart Rate Increased
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Investigations
Occult Blood Positive
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
7.5%
3/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Musculoskeletal and connective tissue disorders
Renal Osteodystrophy
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Nervous system disorders
Migraine
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Psychiatric disorders
Listless
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
3/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Viscosity Of Bronchial Secretion
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
2/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
2.5%
1/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
0.00%
0/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
7.5%
3/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
5.0%
2/40 • Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Treatment-emergent events are presented.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER