Trial Outcomes & Findings for European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa (NCT NCT00838097)
NCT ID: NCT00838097
Last Updated: 2014-08-01
Results Overview
An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).
Recruitment status
COMPLETED
Target enrollment
321 participants
Primary outcome timeframe
2 years
Results posted on
2014-08-01
Participant Flow
First participant was enrolled on 26 February 2008; last participant was enrolled on 24 February 2011.
Participant milestones
| Measure |
Darbepoetin Alfa
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
321
|
|
Overall Study
Received Darbepoetin Alfa
|
319
|
|
Overall Study
COMPLETED
|
145
|
|
Overall Study
NOT COMPLETED
|
176
|
Reasons for withdrawal
| Measure |
Darbepoetin Alfa
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Overall Study
Ineligibility determined
|
6
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Requirement for alternative therapy
|
2
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Death
|
6
|
|
Overall Study
Protocol-specified criteria
|
142
|
Baseline Characteristics
European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
Baseline characteristics by cohort
| Measure |
Darbepoetin Alfa
n=319 Participants
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Age, Customized
< 1 year
|
13 participants
n=5 Participants
|
|
Age, Customized
1 to < 6 years
|
83 participants
n=5 Participants
|
|
Age, Customized
6 to < 12 years
|
90 participants
n=5 Participants
|
|
Age, Customized
≥ 12 years
|
133 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
274 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not recorded
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Full Analysis Set
An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).
Outcome measures
| Measure |
Darbepoetin Alfa
n=319 Participants
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
Serious Adverse Drug Reactions
|
4 participants
|
|
Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
Serious Adverse Events
|
162 participants
|
|
Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
Events of Medical Interest
|
39 participants
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24Population: Full analysis set
Outcome measures
| Measure |
Darbepoetin Alfa
n=319 Participants
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Hemoglobin Concentration by Three Monthly Intervals
Baseline (n=308)
|
11.06 g/dL
95% Confidence Interval 1.62 • Interval 10.88 to 11.24
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 3 (n=260)
|
11.47 g/dL
95% Confidence Interval 1.64 • Interval 11.27 to 11.67
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 6 (n=269)
|
11.34 g/dL
95% Confidence Interval 1.32 • Interval 11.18 to 11.5
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 9 (n=245)
|
11.43 g/dL
95% Confidence Interval 1.50 • Interval 11.24 to 11.62
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 12 (n=214)
|
11.39 g/dL
95% Confidence Interval 1.38 • Interval 11.21 to 11.58
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 15 (n=199)
|
11.26 g/dL
95% Confidence Interval 1.35 • Interval 11.08 to 11.45
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 18 (n=167)
|
11.30 g/dL
95% Confidence Interval 1.50 • Interval 11.08 to 11.53
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 21 (n=154)
|
11.30 g/dL
95% Confidence Interval 1.34 • Interval 11.09 to 11.51
|
|
Hemoglobin Concentration by Three Monthly Intervals
Month 24 (n=151)
|
11.42 g/dL
95% Confidence Interval 1.40 • Interval 11.2 to 11.65
|
SECONDARY outcome
Timeframe: Baseline and Months 1 to 24Population: Full analysis set
Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.
Outcome measures
| Measure |
Darbepoetin Alfa
n=319 Participants
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 11 (n=216)
|
1.72 μg/kg/month
Interval 1.53 to 1.92
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 12 (n=211)
|
1.66 μg/kg/month
Interval 1.49 to 1.85
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Baseline (n=273)
|
1.99 μg/kg/month
Interval 1.82 to 2.18
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 1 (n=311)
|
1.90 μg/kg/month
Interval 1.74 to 2.07
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 2 (n=304)
|
1.91 μg/kg/month
Interval 1.75 to 2.09
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 3 (n=297)
|
1.94 μg/kg/month
Interval 1.76 to 2.14
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 4 (n=287)
|
1.87 μg/kg/month
Interval 1.69 to 2.07
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 5 (n=277)
|
1.82 μg/kg/month
Interval 1.65 to 2.02
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 6 (n=269)
|
1.87 μg/kg/month
Interval 1.69 to 2.08
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 7 (n=256)
|
1.79 μg/kg/month
Interval 1.6 to 2.0
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 8 (n=245)
|
1.79 μg/kg/month
Interval 1.61 to 1.98
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 9 (n=233)
|
1.69 μg/kg/month
Interval 1.52 to 1.89
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 10 (n=227)
|
1.63 μg/kg/month
Interval 1.47 to 1.82
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 13 (n=206)
|
1.58 μg/kg/month
Interval 1.4 to 1.78
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 14 (n=200)
|
1.65 μg/kg/month
Interval 1.46 to 1.86
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 15 (n=193)
|
1.71 μg/kg/month
Interval 1.52 to 1.94
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 16 (n=186)
|
1.71 μg/kg/month
Interval 1.51 to 1.93
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 17 (n=180)
|
1.73 μg/kg/month
Interval 1.54 to 1.96
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 18 (n=170)
|
1.71 μg/kg/month
Interval 1.51 to 1.94
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 19 (n=164)
|
1.71 μg/kg/month
Interval 1.5 to 1.95
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 20 (n=162)
|
1.70 μg/kg/month
Interval 1.48 to 1.96
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 21 (n=157)
|
1.79 μg/kg/month
Interval 1.56 to 2.05
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 22 (n=155)
|
1.70 μg/kg/month
Interval 1.46 to 1.97
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 23 (n=154)
|
1.63 μg/kg/month
Interval 1.41 to 1.88
|
|
Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals
Month 24 (n=146)
|
1.44 μg/kg/month
Interval 1.22 to 1.69
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24Population: Full analysis set
Outcome measures
| Measure |
Darbepoetin Alfa
n=319 Participants
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 6 (n=246)
|
18.12 pmol/L
Inter-Quartile Range 1.32 • Interval 9.87 to 29.4
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 9 (n=225)
|
16.70 pmol/L
Inter-Quartile Range 1.50 • Interval 9.2 to 33.6
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 12 (n=194)
|
19.11 pmol/L
Inter-Quartile Range 1.38 • Interval 8.55 to 33.5
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 15 (n=184)
|
17.51 pmol/L
Inter-Quartile Range 1.35 • Interval 9.57 to 30.67
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 24 (n=137)
|
21.20 pmol/L
Inter-Quartile Range 1.40 • Interval 11.13 to 35.79
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Baseline (n=228)
|
20.44 pmol/L
Inter-Quartile Range 1.62 • Interval 11.82 to 36.81
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 3 (n=236)
|
19.76 pmol/L
Inter-Quartile Range 1.64 • Interval 9.93 to 36.7
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 18 (n=150)
|
17.69 pmol/L
Inter-Quartile Range 1.50 • Interval 9.56 to 36.23
|
|
Parathyroid Hormone Level by Three Monthly Intervals
Month 21 (n=142)
|
18.12 pmol/L
Inter-Quartile Range 1.34 • Interval 8.93 to 36.75
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Full analysis set
An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied: * Fatal * Life threatening * Required or prolonged in-patient hospitalization * A persistent or significant disability/incapacity, or * A congenital anomaly/birth defect.
Outcome measures
| Measure |
Darbepoetin Alfa
n=319 Participants
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Number of Participants With Non-serious Adverse Drug Reactions (ADRs)
|
4 participants
|
Adverse Events
Darbepoetin Alfa
Serious events: 162 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Darbepoetin Alfa
n=319 participants at risk
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.6%
5/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiomegaly
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiomyopathy
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Congenital mitochondrial cytopathy
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Goitre
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Eye disorders
Blindness
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
3/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.94%
3/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dental caries
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
8/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
8/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site haematoma
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site haemorrhage
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Device malfunction
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Hyperthermia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Medical device complication
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Oedema
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
General disorders
Thrombosis in device
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Immune system disorders
Kidney transplant rejection
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Atypical pneumonia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchiolitis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
1.9%
6/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis viral
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Catheter site infection
|
1.9%
6/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related infection
|
1.9%
6/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related sepsis
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erysipelas
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Febrile infection
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Fungal peritonitis
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
6.0%
19/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis viral
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infection
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Keratitis herpetic
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Leishmaniasis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis media
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Paronychia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonitis
|
10.0%
32/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonitis bacterial
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
1.9%
6/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis
|
1.9%
6/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis acute
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
2.2%
7/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal infection
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tonsillitis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
7/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Varicella
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.94%
3/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Investigations
Blood urea increased
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Investigations
Cardiac output increased
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Investigations
HLA marker study positive
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Investigations
International normalised ratio increased
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
6/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.94%
3/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.94%
3/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Aphasia
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Convulsion
|
3.1%
10/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiparesis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Loss of consciousness
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine with aura
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuritis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Partial seizures
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Anuria
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Oliguria
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure chronic
|
2.2%
7/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal impairment
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Priapism
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Social circumstances
Inadequate diet
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Accelerated hypertension
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
4.1%
13/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive crisis
|
1.6%
5/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive emergency
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.94%
3/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombophlebitis
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis limb
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Darbepoetin Alfa
n=319 participants at risk
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
|
|---|---|
|
General disorders
Injection site pain
|
1.3%
4/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Immune system disorders
Drug hypersensitivity
|
0.31%
1/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.63%
2/319 • 2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
|
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 aftercompletion. 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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER