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Trial Outcomes & Findings for Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy (NCT NCT00378014)

NCT ID: NCT00378014

Last Updated: 2015-02-06

Results Overview

This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

276 participants

Primary outcome timeframe

Month 11

Results posted on

2015-02-06

Participant Flow

The core study consisted of 2 periods: 1) during the first one-month period, 276 eligible participants received the same CNI-based immunosuppressive therapy prior to randomization; 2) during the second 11-month study period, 203 participants eligible participants were randomized in a 1:1 ratio to one of the two treatment arms.

Participant milestones

Participant milestones
Measure
Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Core (Randomization to Month 11)
STARTED
101
102
Core (Randomization to Month 11)
Intent-to-treat (ITT) Population
96
98
Core (Randomization to Month 11)
COMPLETED
87
90
Core (Randomization to Month 11)
NOT COMPLETED
14
12
Extension (Month 12 to Month 59)
STARTED
41
40
Extension (Month 12 to Month 59)
COMPLETED
27
26
Extension (Month 12 to Month 59)
NOT COMPLETED
14
14

Reasons for withdrawal

Reasons for withdrawal
Measure
Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Core (Randomization to Month 11)
Adverse Event
1
0
Core (Randomization to Month 11)
Graft loss
1
2
Core (Randomization to Month 11)
Death
5
3
Core (Randomization to Month 11)
Administrative Problems
2
2
Core (Randomization to Month 11)
Lost to Follow-up
0
1
Core (Randomization to Month 11)
Withdrawal by Subject
5
2
Core (Randomization to Month 11)
Protocol deviation
0
1
Core (Randomization to Month 11)
Lack of Efficacy
0
1
Extension (Month 12 to Month 59)
Adverse Event
8
7
Extension (Month 12 to Month 59)
Death
1
2
Extension (Month 12 to Month 59)
Administrative problems
1
0
Extension (Month 12 to Month 59)
Lost to Follow-up
1
1
Extension (Month 12 to Month 59)
Withdrawal by Subject
0
3
Extension (Month 12 to Month 59)
Lack of Efficacy
3
1

Baseline Characteristics

Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Total
n=194 Participants
Total of all reporting groups
Age, Continuous
52.3 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
52.9 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
52.6 Years
STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male
Female
42 Participants
n=5 Participants
30 Participants
n=7 Participants
72 Participants
n=5 Participants
Sex: Female, Male
Male
54 Participants
n=5 Participants
68 Participants
n=7 Participants
122 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Month 11

Population: ITT

This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Calculated Glomerular Filtration Rate (cGFR)
87.9 mL/min
Standard Deviation 32.0
84.1 mL/min
Standard Deviation 34.9

SECONDARY outcome

Timeframe: Month 11

Population: ITT

Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Incidence of Efficacy Failure
20.8 Percentage of participants
20.4 Percentage of participants

SECONDARY outcome

Timeframe: Month 11

Population: ITT

The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Incidence of the Need for a Change in the Immunosuppressive Regimen
80.2 Percentage of participants
73.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 11

Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 5

Population: ITT

This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Renal Function (cGFR)
88.7 mL/min
Standard Deviation 31.0
82.9 mL/min
Standard Deviation 29.4

SECONDARY outcome

Timeframe: Month 11

Population: ITT

The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Incidence of Treated BPAR
13.5 Percentage of Participants
10.2 Percentage of Participants

SECONDARY outcome

Timeframe: Month 11

Population: ITT

Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Patient and Graft Survival
Death
4.3 Percentage of Participants
4.1 Percentage of Participants
Patient and Graft Survival
Graft loss
2.2 Percentage of Participants
2.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Month 5

Population: ITT

HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).

Outcome measures

Outcome measures
Measure
Everolimus
n=96 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=98 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Baseline, negative
64.5 Percentage of participants
55.3 Percentage of participants
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Baseline, positive
0.0 Percentage of participants
0.0 Percentage of participants
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Baseline, not done
35.5 Percentage of participants
44.7 Percentage of participants
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Month 5, negative
62.9 Percentage of participants
38.2 Percentage of participants
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Month 5, positive
1.6 Percentage of participants
13.2 Percentage of participants
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Month 5, not done
35.5 Percentage of participants
48.7 Percentage of participants

SECONDARY outcome

Timeframe: From randomization to Month 11

Population: Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.

Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Outcome measures

Outcome measures
Measure
Everolimus
n=101 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=102 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Adverse Events (serious and non-serious)
98 Number of participants
96 Number of participants
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Serious Adverse Events
67 Number of participants
58 Number of participants
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Deaths
4 Number of participants
4 Number of participants

SECONDARY outcome

Timeframe: Month 12 to Month 59 post-baseline

Population: Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.

Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Outcome measures

Outcome measures
Measure
Everolimus
n=41 Participants
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=40 Participants
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Adverse Events (serious and non-serious)
41 Number of participants
40 Number of participants
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Serious Adverse Events
26 Number of participants
28 Number of participants
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Deaths
1 Number of participants
2 Number of participants

Adverse Events

Everolimus

Serious events: 67 serious events
Other events: 92 other events
Deaths: 0 deaths

Calcineurin Inhibitor (CNI)

Serious events: 58 serious events
Other events: 87 other events
Deaths: 0 deaths

Extension Period - Everolimus

Serious events: 26 serious events
Other events: 39 other events
Deaths: 0 deaths

Extension Period - CNI

Serious events: 28 serious events
Other events: 38 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Everolimus
n=101 participants at risk
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=102 participants at risk
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Extension Period - Everolimus
n=41 participants at risk
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Extension Period - CNI
n=40 participants at risk
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Infections and infestations
CELLULITIS ORBITAL
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Infections and infestations
CEREBRAL TOXOPLASMOSIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
CLOSTRIDIAL INFECTION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
CLOSTRIDIUM COLITIS
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
CYTOMEGALOVIRUS COLITIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
CYTOMEGALOVIRUS INFECTION
0.99%
1/101
4.9%
5/102
2.4%
1/41
0.00%
0/40
Infections and infestations
DEVICE RELATED INFECTION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
DIVERTICULITIS
0.99%
1/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Infections and infestations
ENDOCARDITIS
0.99%
1/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Infections and infestations
ENTEROCOCCAL INFECTION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
ENTEROCOCCAL SEPSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
ERYSIPELAS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
GASTROENTERITIS
0.00%
0/101
0.98%
1/102
2.4%
1/41
5.0%
2/40
Infections and infestations
GASTROENTERITIS NOROVIRUS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
GASTROINTESTINAL INFECTION
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Infections and infestations
HAEMATOMA INFECTION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
HEPATITIS C
3.0%
3/101
2.9%
3/102
0.00%
0/41
2.5%
1/40
Infections and infestations
HERPES ZOSTER
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
INCISIONAL HERNIA GANGRENOUS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
INFECTION
0.99%
1/101
0.00%
0/102
4.9%
2/41
5.0%
2/40
Infections and infestations
LIVER ABSCESS
3.0%
3/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
OESOPHAGEAL CANDIDIASIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
PANCREATITIS BACTERIAL
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
PERIHEPATIC ABSCESS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
PERITONEAL ABSCESS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
PERITONITIS BACTERIAL
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Infections and infestations
PNEUMOCYSTIS JIROVECI PNEUMONIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Psychiatric disorders
DEPRESSION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Psychiatric disorders
DISORIENTATION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Blood and lymphatic system disorders
ANAEMIA
3.0%
3/101
2.0%
2/102
0.00%
0/41
2.5%
1/40
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Blood and lymphatic system disorders
HAEMOLYTIC URAEMIC SYNDROME
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Blood and lymphatic system disorders
LEUKOPENIA
4.0%
4/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Blood and lymphatic system disorders
NEUTROPENIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Blood and lymphatic system disorders
PANCYTOPENIA
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Blood and lymphatic system disorders
THROMBOTIC MICROANGIOPATHY
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Cardiac disorders
ARRHYTHMIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
ATRIAL FIBRILLATION
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Cardiac disorders
ATRIOVENTRICULAR BLOCK
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Cardiac disorders
CARDIAC ARREST
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
CARDIAC FAILURE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
CARDIAC FAILURE ACUTE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
MYOCARDIAL INFARCTION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
PERICARDIAL EFFUSION
2.0%
2/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
TACHYCARDIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Cardiac disorders
TORSADE DE POINTES
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Ear and labyrinth disorders
VERTIGO
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Endocrine disorders
GOITRE
0.99%
1/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Endocrine disorders
HYPERTHYROIDISM
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Endocrine disorders
TOXIC NODULAR GOITRE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Eye disorders
MACULAR OEDEMA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Eye disorders
OCULAR ICTERUS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Eye disorders
PAPILLOEDEMA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Eye disorders
RETINAL HAEMORRHAGE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Eye disorders
RETINAL VEIN OCCLUSION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Eye disorders
RETINITIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
ABDOMINAL HERNIA
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
ABDOMINAL PAIN
4.0%
4/101
2.0%
2/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
ANAL PROLAPSE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
ASCITES
0.00%
0/101
2.0%
2/102
2.4%
1/41
2.5%
1/40
Gastrointestinal disorders
COELIAC ARTERY STENOSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
CROHN'S DISEASE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
DIARRHOEA
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
DYSPHAGIA
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Gastrointestinal disorders
GASTRITIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
GASTRITIS HAEMORRHAGIC
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
ILEUS
0.00%
0/101
2.0%
2/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
ILEUS PARALYTIC
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Gastrointestinal disorders
INGUINAL HERNIA
2.0%
2/101
0.98%
1/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
INTESTINAL DILATATION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
MALABSORPTION
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
MECHANICAL ILEUS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
NAUSEA
0.99%
1/101
2.0%
2/102
0.00%
0/41
2.5%
1/40
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Gastrointestinal disorders
PANCREATIC CYST
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
PANCREATITIS
0.00%
0/101
2.9%
3/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
PANCREATITIS ACUTE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
SMALL INTESTINAL STENOSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
SUBILEUS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Gastrointestinal disorders
UMBILICAL HERNIA
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Gastrointestinal disorders
VOMITING
2.0%
2/101
0.98%
1/102
0.00%
0/41
5.0%
2/40
General disorders
ASTHENIA
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
General disorders
CHEST PAIN
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
CONCOMITANT DISEASE PROGRESSION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
CYST
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
General disorders
DEATH
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
DISEASE PROGRESSION
3.0%
3/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
DRUG INEFFECTIVE
2.0%
2/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
DRUG INTERACTION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
HERNIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
HERNIA PAIN
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
General disorders
INFLAMMATION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
MULTI-ORGAN FAILURE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
General disorders
OEDEMA PERIPHERAL
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
General disorders
PYREXIA
5.9%
6/101
3.9%
4/102
4.9%
2/41
2.5%
1/40
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
BILE DUCT STENOSIS
2.0%
2/101
4.9%
5/102
2.4%
1/41
5.0%
2/40
Hepatobiliary disorders
BILIARY ISCHAEMIA
2.0%
2/101
3.9%
4/102
4.9%
2/41
5.0%
2/40
Hepatobiliary disorders
BILIARY TRACT DISORDER
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
BILOMA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
CHOLANGITIS
4.0%
4/101
9.8%
10/102
2.4%
1/41
7.5%
3/40
Hepatobiliary disorders
CHOLELITHIASIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
CHOLESTASIS
5.0%
5/101
2.0%
2/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
HEPATIC ARTERY OCCLUSION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Hepatobiliary disorders
HEPATIC CIRRHOSIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Hepatobiliary disorders
HEPATIC FAILURE
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Hepatobiliary disorders
HEPATIC HAEMORRHAGE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
HEPATIC LESION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Hepatobiliary disorders
HEPATIC STEATOSIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Hepatobiliary disorders
HEPATIC VEIN THROMBOSIS
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Hepatobiliary disorders
HEPATITIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
HEPATORENAL SYNDROME
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Hepatobiliary disorders
HEPATOTOXICITY
2.0%
2/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Hepatobiliary disorders
NON-ALCOHOLIC STEATOHEPATITIS
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Immune system disorders
HYPERSENSITIVITY
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Immune system disorders
LIVER TRANSPLANT REJECTION
4.0%
4/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Immune system disorders
TRANSPLANT REJECTION
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
ABDOMINAL ABSCESS
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
ASPERGILLOSIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
BILIARY SEPSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
BRAIN ABSCESS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
BRONCHITIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
BRONCHOPNEUMONIA
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
CELLULITIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
PNEUMONIA
5.0%
5/101
2.9%
3/102
2.4%
1/41
5.0%
2/40
Infections and infestations
PNEUMONIA CYTOMEGALOVIRAL
0.99%
1/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
RESPIRATORY TRACT INFECTION
0.99%
1/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Infections and infestations
SEPSIS
2.0%
2/101
2.0%
2/102
2.4%
1/41
0.00%
0/40
Infections and infestations
SEPTIC SHOCK
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
SMALL INTESTINE GANGRENE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Infections and infestations
STENOTROPHOMONAS INFECTION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
TONSILLITIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Infections and infestations
URINARY TRACT INFECTION
0.99%
1/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Infections and infestations
WOUND INFECTION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
ANASTOMOTIC STENOSIS
0.99%
1/101
2.0%
2/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
ANIMAL BITE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Injury, poisoning and procedural complications
BILIARY ANASTOMOSIS COMPLICATION
4.0%
4/101
2.9%
3/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
FALL
0.99%
1/101
0.98%
1/102
7.3%
3/41
2.5%
1/40
Injury, poisoning and procedural complications
FIBULA FRACTURE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Injury, poisoning and procedural complications
FOOT FRACTURE
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Injury, poisoning and procedural complications
INCISIONAL HERNIA
7.9%
8/101
4.9%
5/102
17.1%
7/41
12.5%
5/40
Injury, poisoning and procedural complications
INCISIONAL HERNIA, OBSTRUCTIVE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
LIVER GRAFT LOSS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
0.00%
0/101
2.9%
3/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
2.0%
2/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
RADIUS FRACTURE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Injury, poisoning and procedural complications
RIB FRACTURE
2.0%
2/101
0.00%
0/102
4.9%
2/41
0.00%
0/40
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Injury, poisoning and procedural complications
TIBIA FRACTURE
0.99%
1/101
0.00%
0/102
4.9%
2/41
0.00%
0/40
Injury, poisoning and procedural complications
TRANSPLANT FAILURE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Injury, poisoning and procedural complications
WOUND COMPLICATION
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Injury, poisoning and procedural complications
WRIST FRACTURE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Investigations
BLOOD CREATININE INCREASED
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Investigations
C-REACTIVE PROTEIN INCREASED
2.0%
2/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Investigations
CYTOMEGALOVIRUS TEST POSITIVE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
2.0%
2/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Investigations
HAEMOGLOBIN DECREASED
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Investigations
HEPATIC ENZYME INCREASED
13.9%
14/101
8.8%
9/102
2.4%
1/41
2.5%
1/40
Investigations
LIVER FUNCTION TEST ABNORMAL
3.0%
3/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Investigations
TRANSAMINASES INCREASED
4.0%
4/101
2.9%
3/102
2.4%
1/41
2.5%
1/40
Metabolism and nutrition disorders
DIABETES MELLITUS
0.00%
0/101
2.0%
2/102
0.00%
0/41
0.00%
0/40
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Metabolism and nutrition disorders
HYPERKALAEMIA
0.00%
0/101
2.9%
3/102
0.00%
0/41
0.00%
0/40
Metabolism and nutrition disorders
HYPOGLYCAEMIA
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Metabolism and nutrition disorders
HYPONATRAEMIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Metabolism and nutrition disorders
HYPOVITAMINOSIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Musculoskeletal and connective tissue disorders
ARTHRALGIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Musculoskeletal and connective tissue disorders
ARTHROPATHY
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
BACK PAIN
0.99%
1/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
0.00%
0/101
0.00%
0/102
2.4%
1/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
OSTEOPENIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT RECURRENT
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
0.00%
0/101
0.00%
0/102
4.9%
2/41
2.5%
1/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
0.00%
0/101
0.98%
1/102
2.4%
1/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LYMPH NODES
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARANEOPLASTIC SYNDROME
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
APHASIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
CAROTID ARTERY STENOSIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
CEREBRAL HAEMORRHAGE
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
CEREBRAL INFARCTION
0.99%
1/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Nervous system disorders
CEREBRAL ISCHAEMIA
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
CEREBROVASCULAR ACCIDENT
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
DIZZINESS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
ENCEPHALOPATHY
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
EPILEPSY
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
GRAND MAL CONVULSION
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
HEMIPARESIS
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
LACUNAR INFARCTION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
LETHARGY
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
LOSS OF CONSCIOUSNESS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
MIGRAINE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
NEUROPATHY PERIPHERAL
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
NEUROTOXICITY
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
PARAESTHESIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Nervous system disorders
POLYNEUROPATHY
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Nervous system disorders
RADICULAR SYNDROME
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
SOMNOLENCE
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
SYNCOPE
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Psychiatric disorders
ALCOHOLISM
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Psychiatric disorders
PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Psychiatric disorders
SUICIDE ATTEMPT
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Renal and urinary disorders
HAEMATURIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Renal and urinary disorders
RENAL FAILURE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Renal and urinary disorders
RENAL FAILURE ACUTE
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Renal and urinary disorders
RENAL IMPAIRMENT
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Renal and urinary disorders
RENAL INJURY
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Reproductive system and breast disorders
MENORRHAGIA
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Reproductive system and breast disorders
OVARIAN CYST
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Reproductive system and breast disorders
SPERMATOCELE
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Reproductive system and breast disorders
TESTICULAR SWELLING
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Respiratory, thoracic and mediastinal disorders
COUGH
0.99%
1/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
0.99%
1/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
0.99%
1/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
0.99%
1/101
2.0%
2/102
0.00%
0/41
2.5%
1/40
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
0.00%
0/101
0.00%
0/102
0.00%
0/41
2.5%
1/40
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
0.00%
0/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Respiratory, thoracic and mediastinal disorders
VOCAL CORD POLYP
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Skin and subcutaneous tissue disorders
ANGIOEDEMA
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Skin and subcutaneous tissue disorders
ERYTHEMA
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Skin and subcutaneous tissue disorders
PRURITUS
0.99%
1/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Skin and subcutaneous tissue disorders
SCAR
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Vascular disorders
CIRCULATORY COLLAPSE
0.00%
0/101
0.98%
1/102
2.4%
1/41
0.00%
0/40
Vascular disorders
DEEP VEIN THROMBOSIS
0.00%
0/101
0.00%
0/102
2.4%
1/41
0.00%
0/40
Vascular disorders
HYPERTENSIVE CRISIS
0.99%
1/101
0.98%
1/102
0.00%
0/41
2.5%
1/40
Vascular disorders
SHOCK HAEMORRHAGIC
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Vascular disorders
STEAL SYNDROME
0.99%
1/101
0.00%
0/102
0.00%
0/41
0.00%
0/40
Vascular disorders
VENA CAVA THROMBOSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40
Vascular disorders
VENOUS STENOSIS
0.00%
0/101
0.98%
1/102
0.00%
0/41
0.00%
0/40

Other adverse events

Other adverse events
Measure
Everolimus
n=101 participants at risk
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Calcineurin Inhibitor (CNI)
n=102 participants at risk
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Extension Period - Everolimus
n=41 participants at risk
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Extension Period - CNI
n=40 participants at risk
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Blood and lymphatic system disorders
ANAEMIA
16.8%
17/101
9.8%
10/102
9.8%
4/41
2.5%
1/40
Blood and lymphatic system disorders
LEUKOPENIA
18.8%
19/101
9.8%
10/102
2.4%
1/41
7.5%
3/40
Blood and lymphatic system disorders
THROMBOCYTOPENIA
7.9%
8/101
6.9%
7/102
4.9%
2/41
10.0%
4/40
Cardiac disorders
TACHYCARDIA
5.9%
6/101
2.0%
2/102
0.00%
0/41
0.00%
0/40
Endocrine disorders
HYPOTHYROIDISM
0.00%
0/101
0.00%
0/102
2.4%
1/41
5.0%
2/40
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
2.0%
2/101
0.98%
1/102
0.00%
0/41
5.0%
2/40
Gastrointestinal disorders
ABDOMINAL PAIN
10.9%
11/101
9.8%
10/102
9.8%
4/41
5.0%
2/40
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
5.9%
6/101
5.9%
6/102
12.2%
5/41
5.0%
2/40
Gastrointestinal disorders
APHTHOUS STOMATITIS
7.9%
8/101
0.98%
1/102
4.9%
2/41
0.00%
0/40
Gastrointestinal disorders
ASCITES
0.99%
1/101
7.8%
8/102
2.4%
1/41
5.0%
2/40
Gastrointestinal disorders
CONSTIPATION
8.9%
9/101
10.8%
11/102
2.4%
1/41
7.5%
3/40
Gastrointestinal disorders
DIARRHOEA
26.7%
27/101
12.7%
13/102
24.4%
10/41
10.0%
4/40
Gastrointestinal disorders
FLATULENCE
6.9%
7/101
9.8%
10/102
12.2%
5/41
5.0%
2/40
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
2.0%
2/101
0.98%
1/102
9.8%
4/41
5.0%
2/40
Gastrointestinal disorders
NAUSEA
11.9%
12/101
15.7%
16/102
12.2%
5/41
7.5%
3/40
Gastrointestinal disorders
VOMITING
5.9%
6/101
11.8%
12/102
7.3%
3/41
0.00%
0/40
General disorders
FATIGUE
5.0%
5/101
5.9%
6/102
4.9%
2/41
7.5%
3/40
General disorders
IMPAIRED HEALING
0.00%
0/101
0.98%
1/102
4.9%
2/41
5.0%
2/40
General disorders
OEDEMA
5.0%
5/101
5.9%
6/102
0.00%
0/41
0.00%
0/40
General disorders
OEDEMA PERIPHERAL
14.9%
15/101
8.8%
9/102
31.7%
13/41
7.5%
3/40
General disorders
PYREXIA
13.9%
14/101
11.8%
12/102
9.8%
4/41
7.5%
3/40
Hepatobiliary disorders
CHOLANGITIS
5.9%
6/101
4.9%
5/102
2.4%
1/41
2.5%
1/40
Hepatobiliary disorders
CHOLESTASIS
8.9%
9/101
3.9%
4/102
4.9%
2/41
2.5%
1/40
Hepatobiliary disorders
HEPATIC STEATOSIS
2.0%
2/101
3.9%
4/102
14.6%
6/41
12.5%
5/40
Infections and infestations
BRONCHITIS
2.0%
2/101
0.98%
1/102
14.6%
6/41
15.0%
6/40
Infections and infestations
CYTOMEGALOVIRUS INFECTION
6.9%
7/101
6.9%
7/102
2.4%
1/41
0.00%
0/40
Infections and infestations
NASOPHARYNGITIS
14.9%
15/101
14.7%
15/102
22.0%
9/41
20.0%
8/40
Infections and infestations
PERIODONTITIS
0.00%
0/101
0.00%
0/102
12.2%
5/41
5.0%
2/40
Infections and infestations
SINUSITIS
5.9%
6/101
0.98%
1/102
9.8%
4/41
2.5%
1/40
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
0.99%
1/101
2.0%
2/102
9.8%
4/41
2.5%
1/40
Infections and infestations
URINARY TRACT INFECTION
15.8%
16/101
12.7%
13/102
14.6%
6/41
10.0%
4/40
Infections and infestations
WOUND INFECTION
6.9%
7/101
2.0%
2/102
4.9%
2/41
0.00%
0/40
Injury, poisoning and procedural complications
INCISIONAL HERNIA
4.0%
4/101
4.9%
5/102
17.1%
7/41
5.0%
2/40
Injury, poisoning and procedural complications
PROCEDURAL PAIN
4.0%
4/101
7.8%
8/102
7.3%
3/41
2.5%
1/40
Investigations
C-REACTIVE PROTEIN INCREASED
7.9%
8/101
2.0%
2/102
4.9%
2/41
2.5%
1/40
Investigations
HEPATIC ENZYME INCREASED
13.9%
14/101
2.9%
3/102
0.00%
0/41
10.0%
4/40
Investigations
TRANSAMINASES INCREASED
7.9%
8/101
5.9%
6/102
9.8%
4/41
2.5%
1/40
Investigations
WEIGHT DECREASED
0.99%
1/101
0.98%
1/102
2.4%
1/41
5.0%
2/40
Metabolism and nutrition disorders
DIABETES MELLITUS
4.0%
4/101
5.9%
6/102
12.2%
5/41
5.0%
2/40
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
21.8%
22/101
10.8%
11/102
9.8%
4/41
5.0%
2/40
Metabolism and nutrition disorders
HYPERKALAEMIA
0.99%
1/101
6.9%
7/102
0.00%
0/41
5.0%
2/40
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
11.9%
12/101
2.0%
2/102
2.4%
1/41
0.00%
0/40
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
5.9%
6/101
2.9%
3/102
4.9%
2/41
2.5%
1/40
Metabolism and nutrition disorders
HYPERURICAEMIA
5.0%
5/101
6.9%
7/102
4.9%
2/41
7.5%
3/40
Metabolism and nutrition disorders
HYPOKALAEMIA
12.9%
13/101
8.8%
9/102
7.3%
3/41
2.5%
1/40
Metabolism and nutrition disorders
OBESITY
0.00%
0/101
0.00%
0/102
0.00%
0/41
5.0%
2/40
Musculoskeletal and connective tissue disorders
ARTHRALGIA
6.9%
7/101
9.8%
10/102
7.3%
3/41
5.0%
2/40
Musculoskeletal and connective tissue disorders
BACK PAIN
11.9%
12/101
12.7%
13/102
22.0%
9/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
4.0%
4/101
6.9%
7/102
2.4%
1/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
OSTEOPENIA
0.00%
0/101
2.9%
3/102
4.9%
2/41
5.0%
2/40
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
2.0%
2/101
3.9%
4/102
14.6%
6/41
2.5%
1/40
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
5.0%
5/101
5.9%
6/102
17.1%
7/41
0.00%
0/40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
0.99%
1/101
0.00%
0/102
0.00%
0/41
5.0%
2/40
Nervous system disorders
HEADACHE
19.8%
20/101
9.8%
10/102
7.3%
3/41
2.5%
1/40
Nervous system disorders
PARAESTHESIA
4.0%
4/101
3.9%
4/102
7.3%
3/41
2.5%
1/40
Nervous system disorders
TREMOR
5.9%
6/101
8.8%
9/102
0.00%
0/41
0.00%
0/40
Psychiatric disorders
DEPRESSION
3.0%
3/101
5.9%
6/102
4.9%
2/41
17.5%
7/40
Psychiatric disorders
INSOMNIA
7.9%
8/101
8.8%
9/102
2.4%
1/41
5.0%
2/40
Psychiatric disorders
SLEEP DISORDER
4.0%
4/101
5.9%
6/102
9.8%
4/41
2.5%
1/40
Renal and urinary disorders
PROTEINURIA
9.9%
10/101
2.0%
2/102
9.8%
4/41
0.00%
0/40
Renal and urinary disorders
RENAL FAILURE
3.0%
3/101
6.9%
7/102
4.9%
2/41
15.0%
6/40
Renal and urinary disorders
RENAL FAILURE CHRONIC
0.00%
0/101
2.0%
2/102
0.00%
0/41
5.0%
2/40
Renal and urinary disorders
URINARY INCONTINENCE
0.00%
0/101
0.00%
0/102
0.00%
0/41
5.0%
2/40
Reproductive system and breast disorders
METRORRHAGIA
0.99%
1/101
0.00%
0/102
0.00%
0/41
5.0%
2/40
Respiratory, thoracic and mediastinal disorders
COUGH
5.9%
6/101
0.98%
1/102
9.8%
4/41
5.0%
2/40
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
5.9%
6/101
4.9%
5/102
0.00%
0/41
0.00%
0/40
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
8.9%
9/101
7.8%
8/102
2.4%
1/41
0.00%
0/40
Skin and subcutaneous tissue disorders
PRURITUS
18.8%
19/101
10.8%
11/102
12.2%
5/41
10.0%
4/40
Skin and subcutaneous tissue disorders
RASH
5.0%
5/101
0.98%
1/102
2.4%
1/41
7.5%
3/40
Vascular disorders
HYPERTENSION
19.8%
20/101
13.7%
14/102
14.6%
6/41
15.0%
6/40

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
  • Publication restrictions are in place

Restriction type: OTHER