Trial Outcomes & Findings for Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. (NCT NCT00632125)
NCT ID: NCT00632125
Last Updated: 2017-07-11
Results Overview
The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1695 participants
Primary outcome timeframe
6 months
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
HX575
HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the summary of product characteristics (SmPC)
|
|---|---|
|
Overall Study
STARTED
|
1695
|
|
Overall Study
COMPLETED
|
1393
|
|
Overall Study
NOT COMPLETED
|
302
|
Reasons for withdrawal
| Measure |
HX575
HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the summary of product characteristics (SmPC)
|
|---|---|
|
Overall Study
Death
|
82
|
|
Overall Study
Withdrawal by Subject
|
44
|
|
Overall Study
Adverse Event
|
36
|
|
Overall Study
Renal transplantation
|
17
|
|
Overall Study
Need for systemic immunosuppressive medi
|
8
|
|
Overall Study
Non-compliance
|
8
|
|
Overall Study
Development of uncontrolled hypertension
|
5
|
|
Overall Study
Moved to other dialysis unit, etc.
|
102
|
Baseline Characteristics
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Baseline characteristics by cohort
| Measure |
HX575
n=1695 Participants
HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the SmPC
|
|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
737 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
958 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1671 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
103 participants
n=5 Participants
|
|
Region of Enrollment
Macedonia, The Former Yugoslav Republic of
|
143 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
204 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
220 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
205 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
45 participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
701 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety population: The safety population consists of all patients that received at least one dose of study drug
The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy
Outcome measures
| Measure |
HX575
n=1695 Participants
HX575 administered i.v. according to the SmPC
|
|---|---|
|
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
Drug-related AEs
|
7 percentage of participants
Interval 5.9 to 8.3
|
|
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
EPO-related lack of efficacy events
|
0.18 percentage of participants
Interval 0.04 to 0.52
|
Adverse Events
HX575
Serious events: 456 serious events
Other events: 1314 other events
Deaths: 82 deaths
Serious adverse events
| Measure |
HX575
n=1695 participants at risk
HX575 administered i.v. according to the SmPC
|
|---|---|
|
Infections and infestations
Pneumonia
|
2.0%
34/1695 • Number of events 35
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.4%
24/1695 • Number of events 28
|
|
Cardiac disorders
Atrial fibrillation
|
0.77%
13/1695 • Number of events 14
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
11/1695 • Number of events 11
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.65%
11/1695 • Number of events 11
|
|
General disorders
Pyrexia
|
0.47%
8/1695 • Number of events 8
|
|
Nervous system disorders
Cerebrovascular accident
|
0.53%
9/1695 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.35%
6/1695 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.41%
7/1695 • Number of events 7
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.41%
7/1695 • Number of events 8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.12%
2/1695 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.18%
3/1695 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
7/1695 • Number of events 7
|
|
Renal and urinary disorders
Haematuria
|
0.12%
2/1695 • Number of events 2
|
|
Investigations
Blood glucose fluctuation
|
0.12%
2/1695 • Number of events 2
|
|
Eye disorders
Cataract
|
0.12%
2/1695 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.29%
5/1695 • Number of events 5
|
|
Immune system disorders
Amyloidosis
|
0.12%
2/1695 • Number of events 2
|
|
Psychiatric disorders
Bipolar I disorder
|
0.06%
1/1695 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
2/1695 • Number of events 2
|
|
Endocrine disorders
Hyperparathyroidism
|
0.12%
2/1695 • Number of events 2
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.06%
1/1695 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.06%
1/1695 • Number of events 1
|
|
Social circumstances
Immobilisation prolonged
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Sepsis
|
0.94%
16/1695 • Number of events 16
|
|
Infections and infestations
Bronchitis
|
0.53%
9/1695 • Number of events 9
|
|
Infections and infestations
Cellulitis
|
0.35%
6/1695 • Number of events 6
|
|
Infections and infestations
Gastroenteritis
|
0.29%
5/1695 • Number of events 5
|
|
Infections and infestations
Diverticulitis
|
0.24%
4/1695 • Number of events 4
|
|
Infections and infestations
Gangrene
|
0.24%
4/1695 • Number of events 4
|
|
Infections and infestations
Bronchopneumonia
|
0.18%
3/1695 • Number of events 3
|
|
Infections and infestations
Infection
|
0.18%
3/1695 • Number of events 3
|
|
Infections and infestations
Respiratory tract infection
|
0.18%
3/1695 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.18%
3/1695 • Number of events 3
|
|
Infections and infestations
Urosepsis
|
0.18%
3/1695 • Number of events 3
|
|
Infections and infestations
Viral infection
|
0.18%
3/1695 • Number of events 3
|
|
Infections and infestations
Diabetic foot infection
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Endocarditis
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Localised infection
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Osteomyelitis
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Shunt infection
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Staphylococcal sepsis
|
0.12%
2/1695 • Number of events 2
|
|
Infections and infestations
Abscess
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Bacterial sepsis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Candida sepsis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Cardiac valve abscess
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Catheter sepsis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Catheter site infection
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Diabetic gangrene
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Enterobacter sepsis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Escherichia sepsis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Febrile infection
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Fungal oesophagitis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Hepatitis C
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Infected cyst
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Infected skin ulcer
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Infective spondylitis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Intervertebral discitis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Osteomyelitis chronic
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Peritonitis bacterial
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Pyothorax
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Salmonellosis
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Scrotal abscess
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.06%
1/1695 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
1.0%
17/1695 • Number of events 17
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.65%
11/1695 • Number of events 13
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.47%
8/1695 • Number of events 8
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.47%
8/1695 • Number of events 8
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.41%
7/1695 • Number of events 7
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
6/1695 • Number of events 7
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.18%
3/1695 • Number of events 4
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.18%
3/1695 • Number of events 3
|
|
Injury, poisoning and procedural complications
Concussion
|
0.18%
3/1695 • Number of events 3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.18%
3/1695 • Number of events 3
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
3/1695 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fracture
|
0.12%
2/1695 • Number of events 2
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
2/1695 • Number of events 2
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.12%
2/1695 • Number of events 2
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.12%
2/1695 • Number of events 2
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.12%
2/1695 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.06%
1/1695 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.06%
1/1695 • Number of events 2
|
|
Cardiac disorders
Cardiac failure
|
0.65%
11/1695 • Number of events 13
|
|
Cardiac disorders
Cardiac arrest
|
0.59%
10/1695 • Number of events 10
|
|
Cardiac disorders
Myocardial infarction
|
0.59%
10/1695 • Number of events 10
|
|
Cardiac disorders
Coronary artery disease
|
0.35%
6/1695 • Number of events 6
|
|
Cardiac disorders
Acute coronary syndrome
|
0.29%
5/1695 • Number of events 5
|
|
Cardiac disorders
Angina pectoris
|
0.29%
5/1695 • Number of events 5
|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
4/1695 • Number of events 4
|
|
Cardiac disorders
Cardiac failure acute
|
0.24%
4/1695 • Number of events 4
|
|
Cardiac disorders
Myocardial ischaemia
|
0.24%
4/1695 • Number of events 4
|
|
Cardiac disorders
Aortic valve stenosis
|
0.18%
3/1695 • Number of events 3
|
|
Cardiac disorders
Tachyarrhythmia
|
0.18%
3/1695 • Number of events 3
|
|
Cardiac disorders
Ventricular fibrillation
|
0.18%
3/1695 • Number of events 3
|
|
Cardiac disorders
Atrioventricular block
|
0.12%
2/1695 • Number of events 2
|
|
Cardiac disorders
Cardiogenic shock
|
0.12%
2/1695 • Number of events 2
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.12%
2/1695 • Number of events 2
|
|
Cardiac disorders
Left ventricular failure
|
0.12%
2/1695 • Number of events 2
|
|
Cardiac disorders
Sick sinus syndrome
|
0.12%
2/1695 • Number of events 2
|
|
Cardiac disorders
Angina unstable
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Aortic valve disease
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Aortic valve incompetence
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Bundle branch block right
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Cardiac failure chronic
|
0.06%
1/1695 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Cardiac fibrillation
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Coronary artery stenosis
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Mitral valve stenosis
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.06%
1/1695 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
7/1695 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
6/1695 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
5/1695 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
4/1695 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
0.18%
3/1695 • Number of events 3
|
|
Gastrointestinal disorders
Faecaloma
|
0.18%
3/1695 • Number of events 3
|
|
Gastrointestinal disorders
Ileus
|
0.18%
3/1695 • Number of events 3
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.18%
3/1695 • Number of events 3
|
|
Gastrointestinal disorders
Peritonitis
|
0.18%
3/1695 • Number of events 3
|
|
Gastrointestinal disorders
Subileus
|
0.18%
3/1695 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Melaena
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.12%
2/1695 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Acute abdomen
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Gastric disorder
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.06%
1/1695 • Number of events 1
|
|
Gastrointestinal disorders
Swollen tongue
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.59%
10/1695 • Number of events 10
|
|
Vascular disorders
Hypotension
|
0.29%
5/1695 • Number of events 5
|
|
Vascular disorders
Extremity necrosis
|
0.24%
4/1695 • Number of events 4
|
|
Vascular disorders
Venous thrombosis
|
0.24%
4/1695 • Number of events 4
|
|
Vascular disorders
Circulatory collapse
|
0.18%
3/1695 • Number of events 3
|
|
Vascular disorders
Steal syndrome
|
0.18%
3/1695 • Number of events 3
|
|
Vascular disorders
Angiopathy
|
0.12%
2/1695 • Number of events 3
|
|
Vascular disorders
Arterial occlusive disease
|
0.12%
2/1695 • Number of events 2
|
|
Vascular disorders
Arteriosclerosis
|
0.12%
2/1695 • Number of events 2
|
|
Vascular disorders
Haematoma
|
0.12%
2/1695 • Number of events 2
|
|
Vascular disorders
Haemorrhage
|
0.12%
2/1695 • Number of events 2
|
|
Vascular disorders
Hypertensive crisis
|
0.12%
2/1695 • Number of events 2
|
|
Vascular disorders
Peripheral ischaemia
|
0.12%
2/1695 • Number of events 2
|
|
Vascular disorders
Air embolism
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Hypertensive emergency
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Ischaemic limb pain
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Labile blood pressure
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Lymphocele
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Vascular occlusion
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Vascular pseudoaneurysm ruptured
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
0.06%
1/1695 • Number of events 1
|
|
Vascular disorders
Venous stenosis
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Chest pain
|
0.35%
6/1695 • Number of events 6
|
|
General disorders
Sudden death
|
0.35%
6/1695 • Number of events 6
|
|
General disorders
Catheter related complication
|
0.29%
5/1695 • Number of events 6
|
|
General disorders
General physical health deterioration
|
0.24%
4/1695 • Number of events 4
|
|
General disorders
Multi-organ failure
|
0.12%
2/1695 • Number of events 2
|
|
General disorders
Sudden cardiac death
|
0.12%
2/1695 • Number of events 2
|
|
General disorders
Asthenia
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Catheter site inflammation
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Catheter site pain
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Catheter thrombosis
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Chills
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Condition aggravated
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Cyst
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Cyst rupture
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Death
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Inflammation
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Necrosis
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Orthostatic intolerance
|
0.06%
1/1695 • Number of events 1
|
|
General disorders
Pain
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.18%
3/1695 • Number of events 3
|
|
Nervous system disorders
Syncope
|
0.18%
3/1695 • Number of events 3
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
3/1695 • Number of events 3
|
|
Nervous system disorders
Aphasia
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Brain oedema
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Cerebral ischaemia
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Dementia
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Epilepsy
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Sciatica
|
0.12%
2/1695 • Number of events 2
|
|
Nervous system disorders
Carotid artery stenosis
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Cerebral haematoma
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.06%
1/1695 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.06%
1/1695 • Number of events 1
|
|
Metabolism and nutrition disorders
Cachexia
|
0.29%
5/1695 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.18%
3/1695 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.18%
3/1695 • Number of events 3
|
|
Metabolism and nutrition disorders
Acidosis
|
0.12%
2/1695 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.12%
2/1695 • Number of events 2
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.12%
2/1695 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.12%
2/1695 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
0.06%
1/1695 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1695 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.06%
1/1695 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.06%
1/1695 • Number of events 3
|
|
Metabolism and nutrition disorders
Gout
|
0.06%
1/1695 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
1/1695 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.35%
6/1695 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
5/1695 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
4/1695 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.12%
2/1695 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.06%
1/1695 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.06%
1/1695 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Catheter placement
|
0.12%
2/1695 • Number of events 2
|
|
Surgical and medical procedures
Leg amputation
|
0.12%
2/1695 • Number of events 2
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.12%
2/1695 • Number of events 2
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Cataract operation
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Catheter removal
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Foot amputation
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
High frequency ablation
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Medical device implantation
|
0.06%
1/1695 • Number of events 1
|
|
Surgical and medical procedures
Nephrectomy
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.06%
1/1695 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.06%
1/1695 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
2/1695 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.06%
1/1695 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
1/1695 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.06%
1/1695 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.06%
1/1695 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.06%
1/1695 • Number of events 1
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.06%
1/1695 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.12%
2/1695 • Number of events 2
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.06%
1/1695 • Number of events 1
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.06%
1/1695 • Number of events 1
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.06%
1/1695 • Number of events 1
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.06%
1/1695 • Number of events 1
|
|
Renal and urinary disorders
Renal disorder
|
0.06%
1/1695 • Number of events 1
|
|
Renal and urinary disorders
Renal mass
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
Angiogram peripheral
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
Cardiac enzymes increased
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
General physical condition abnormal
|
0.06%
1/1695 • Number of events 1
|
|
Investigations
Paracentesis abdomen
|
0.06%
1/1695 • Number of events 1
|
|
Eye disorders
Vitreous haemorrhage
|
0.12%
2/1695 • Number of events 2
|
|
Eye disorders
Amaurosis
|
0.06%
1/1695 • Number of events 1
|
|
Eye disorders
Blindness unilateral
|
0.06%
1/1695 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.06%
1/1695 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.06%
1/1695 • Number of events 1
|
|
Eye disorders
Ulcerative keratitis
|
0.06%
1/1695 • Number of events 1
|
|
Eye disorders
Visual acuity reduced
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.06%
1/1695 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.06%
1/1695 • Number of events 1
|
|
Immune system disorders
Cryoglobulinaemia
|
0.06%
1/1695 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.06%
1/1695 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
0.06%
1/1695 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.06%
1/1695 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
0.06%
1/1695 • Number of events 1
|
Other adverse events
| Measure |
HX575
n=1695 participants at risk
HX575 administered i.v. according to the SmPC
|
|---|---|
|
Infections and infestations
Bronchitis
|
8.0%
136/1695 • Number of events 163
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
100/1695 • Number of events 111
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
161/1695 • Number of events 208
|
|
Gastrointestinal disorders
Nausea
|
6.2%
105/1695 • Number of events 148
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
102/1695 • Number of events 121
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.2%
223/1695 • Number of events 429
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
6.5%
111/1695 • Number of events 194
|
|
Vascular disorders
Hypertension
|
10.3%
174/1695 • Number of events 342
|
|
Vascular disorders
Hypotension
|
8.6%
145/1695 • Number of events 298
|
|
Nervous system disorders
Headache
|
10.7%
181/1695 • Number of events 299
|
Additional Information
Biopharmaceutical Clinical Development, Strategic Planning
Sandoz
Phone: 0049 80244760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
- Publication restrictions are in place
Restriction type: OTHER