Trial Outcomes & Findings for A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients (NCT NCT00332462)

Last Updated: 2011-03-07

Results Overview

Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

3 months

Results posted on

2011-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Cyclosporine (Sandimmun®) Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Overall Study STARTED	34
Overall Study Patients Treated With Sandimmun® i.v.	34
Overall Study Patients Treated With Sandimmun® Optoral	29
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Cyclosporine (Sandimmun®) Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Overall Study Adverse Event	5
Overall Study Abnormal Lab Value	1
Overall Study Unsatisfactory therapeutic effect	4
Overall Study no longer requires study drug	1
Overall Study Death	3
Overall Study Graft Loss	2

Baseline Characteristics

A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclosporine (Sandimmun®) n=34 Participants Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Age Continuous	53.2 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intention to treat (ITT) population

Outcome measures

Outcome measures
Measure	Cyclosporine (Sandimmun®) n=34 Participants Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.	6 Months After Transplantation
Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation patients with BPAR within 3 months after Tx : YES	8 Participants	—
Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation patients with BPAR within 3 months after Tx : NO	26 Participants	—

SECONDARY outcome

Timeframe: 3 or 6 months after transplantation

Population: Intention-to-treat (ITT) population.

The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.

Outcome measures

Outcome measures
Measure	Cyclosporine (Sandimmun®) n=34 Participants Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.	6 Months After Transplantation n=34 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Patients with BPAR : YES	NA Participants analysis was done for 6 month only	10 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Patients with BPAR : NO	NA Participants analysis was done for 6 month only	24 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Patients with TAR : YES	7 Participants	8 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Patients with TAR : NO	27 Participants	26 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Patients w/ steroid-resistant acute rejection:YES	2 Participants	3 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Patients w/ steroid-resistant acute rejection:NO	32 Participants	31 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation BPAR w/ moderate/severe histological grading:YES	4 Participants	4 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation BPAR w/ moderate/severe histological grading:NO	30 Participants	30 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Occurence of Death : YES	3 Participants	3 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Occurence of Death : NO	31 Participants	31 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Occurence of Graft loss : YES	3 Participants	3 Participants
Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation Occurence of Graft loss : NO	31 Participants	31 Participants

Adverse Events

Cyclosporine (Sandimmun® i.v.)

Serious events: 18 serious events

Other events: 34 other events

Deaths: 0 deaths

Cyclosporine (Sandimmun® Optoral)

Serious events: 14 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cyclosporine (Sandimmun® i.v.) n=34 participants at risk Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.	Cyclosporine (Sandimmun® Optoral) n=29 participants at risk Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	8.8% 3/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Cardiac disorders ATRIAL FLUTTER	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Cardiac disorders CARDIAC ARREST	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Cardiac disorders CARDIAC FAILURE	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Gastrointestinal disorders ASCITES	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	6.9% 2/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Gastrointestinal disorders PERITONEAL HAEMATOMA	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
General disorders HERNIA	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
General disorders MULTI-ORGAN FAILURE	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
General disorders SYSTEMIC LEAKAGE	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Hepatobiliary disorders BILE DUCT OBSTRUCTION	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Hepatobiliary disorders BILE DUCT STENOSIS	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Hepatobiliary disorders BILIARY ISCHAEMIA	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	6.9% 2/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Hepatobiliary disorders CHOLANGITIS	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	10.3% 3/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Hepatobiliary disorders CHOLANGITIS SCLEROSING	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Immune system disorders GRAFT VERSUS HOST DISEASE	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Immune system disorders LIVER TRANSPLANT REJECTION	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations CYTOMEGALOVIRUS COLITIS	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations CYTOMEGALOVIRUS INFECTION	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations DIARRHOEA INFECTIOUS	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations HEPATITIS B	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations INFECTION	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	6.9% 2/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations PNEUMONIA	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Infections and infestations SEPSIS	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Injury, poisoning and procedural complications ABDOMINAL WOUND DEHISCENCE	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Injury, poisoning and procedural complications COMPLICATIONS OF TRANSPLANTED LIVER	5.9% 2/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Injury, poisoning and procedural complications HEPATIC HAEMATOMA	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	5.9% 2/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Injury, poisoning and procedural complications SEROMA	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Investigations FIBRINOLYSIS INCREASED	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Investigations HEPATIC ENZYME INCREASED	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Investigations HEPATITIS C VIRUS	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE TUMOUR	0.00% 0/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	3.4% 1/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Nervous system disorders ENCEPHALOPATHY	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Renal and urinary disorders ANURIA	2.9% 1/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Renal and urinary disorders RENAL FAILURE	5.9% 2/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	6.9% 2/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Renal and urinary disorders RENAL FAILURE ACUTE	5.9% 2/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
Vascular disorders HAEMORRHAGE	14.7% 5/34 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).	0.00% 0/29 34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).