Trial Outcomes & Findings for A Research Study for Patients With End-Stage Renal Disease (ESRD) (NCT NCT00110890)
NCT ID: NCT00110890
Last Updated: 2011-03-07
Results Overview
Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
552 participants
Primary outcome timeframe
Efficacy Assessment Phase (weeks 17 to 23)
Results posted on
2011-03-07
Participant Flow
Participants were enrolled from 28 May 2004 through 12 November 2004
Participant milestones
| Measure |
Cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Overall Study
STARTED
|
368
|
184
|
|
Overall Study
End of Dose Optimization Phase
|
316
|
170
|
|
Overall Study
End of Efficacy Assessment Phase
|
280
|
150
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
361
|
179
|
Reasons for withdrawal
| Measure |
Cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Overall Study
Adverse Event
|
30
|
7
|
|
Overall Study
Death
|
16
|
9
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Physician Decision
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
17
|
5
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Noncompliance
|
10
|
0
|
|
Overall Study
Kidney Transplant
|
16
|
12
|
|
Overall Study
Invest. Product Commercially Available
|
217
|
110
|
|
Overall Study
Other
|
34
|
23
|
|
Overall Study
Ineligibility determined
|
3
|
0
|
|
Overall Study
Requirement for alternative therapy
|
0
|
1
|
|
Overall Study
Disease progression
|
0
|
1
|
|
Overall Study
Parathyroidectomy
|
0
|
1
|
|
Overall Study
Did not enter follow-up phase
|
10
|
4
|
Baseline Characteristics
A Research Study for Patients With End-Stage Renal Disease (ESRD)
Baseline characteristics by cohort
| Measure |
Cinacalcet
n=368 Participants
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
n=184 Participants
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.5 Years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
58.4 Years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
224 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
349 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
521 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Baseline Strata
Vitamin D prescribed and Ca x P ≤ 55 mg^2/dL^2
|
158 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Baseline Strata
Vitamin D prescribed and Ca x P > 55 mg^2/dL^2
|
94 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Baseline Strata
Vitamin D not prescribed and Ca x P ≤ 55 mg^2/dL^2
|
69 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Baseline Strata
Vitamin D not prescribed and Ca x P > 55 mg^2/dL^2
|
47 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Efficacy Assessment Phase (weeks 17 to 23)Population: Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)
Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet
n=368 Participants
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
n=184 Participants
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Number of Participants With Mean PTH ≤ 300 pg/mL
|
262 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Efficacy Assesment Phase (weeks 17-23)Population: Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)
Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet
n=368 Participants
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
n=184 Participants
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL
|
217 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Efficacy Assessment Phase (weeks 17 to 23)Population: Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)
Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet
n=368 Participants
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
n=184 Participants
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Number of Participants With Mean Ca x P < 55 mg^2/dL^2
|
282 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Efficacy Assessment Phase (weeks 17-23)Population: Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)
Number of participants with mean serum calcium (Ca) \< 9.5 mg/dL during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet
n=368 Participants
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
n=184 Participants
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Number of Participants With Mean Serum Ca < 9.5 mg/dL
|
281 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Efficacy Assessment Phase (weeks 17 to 23)Population: Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)
Number of participants with mean serum phosphorus (P) \< 5.5 mg/dL during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet
n=368 Participants
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
|
Standard of Care
n=184 Participants
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
|
|---|---|---|
|
Number of Participants With Mean Serum P < 5.5 mg/dL
|
231 Participants
|
92 Participants
|
Adverse Events
Standard Care
Serious events: 31 serious events
Other events: 31 other events
Deaths: 0 deaths
Cinacalcet
Serious events: 83 serious events
Other events: 173 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care
n=182 participants at risk
|
Cinacalcet
n=365 participants at risk
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Graft infection
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Influenza
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Perianal abscess
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Renal cyst infection
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.82%
3/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.1%
2/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood potassium increased
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.82%
3/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest discomfort
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chills
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
General physical health deterioration
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Hernia
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Impaired healing
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Multi-organ failure
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Sudden cardiac death
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Sudden death
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Jaundice
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Transplant rejection
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Arthritis bacterial
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacterial sepsis
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Catheter related infection
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Clostridium bacteraemia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina pectoris
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.82%
3/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac asthma
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Pericarditis
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.1%
4/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
2/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter related complication
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiolipoma
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Brain stem ischaemia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral infarction
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cognitive disorder
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.82%
3/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Catheter placement
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Nephrectomy
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertensive crisis
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.55%
1/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Phlebothrombosis
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.27%
1/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Shock
|
0.00%
0/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.55%
2/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Standard Care
n=182 participants at risk
|
Cinacalcet
n=365 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
12/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.9%
47/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
6/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
31.5%
115/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
12/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.8%
87/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
6/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
27/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
5/182 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.2%
19/365 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER