Trial Outcomes & Findings for Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients (NCT NCT01649427)
NCT ID: NCT01649427
Last Updated: 2019-06-17
Results Overview
Change in Nankivell glomerular filtration rate (GFR) from baseline to 6 months Glomerular Filtration Rate (GFR): The GFR is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. Several studies have shown that in patients with progressive renal disease, GFR declines or reciprocal serum creatinine levels elevate linearly over time in a predictable manner. With the help of the serum creatinine values, the GFR was calculated via Nankivell formula.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
73 participants
Primary outcome timeframe
baseline to month 6
Results posted on
2019-06-17
Participant Flow
81 patients were randomized, but only 73 were assigned drug. 1 patient who was excluded from efficacy analyses, was randomized to Prograf but did not receive treatment but kept for safety reporting. 74 patients were used for safety analysis while only 73 were available for efficacy analysis
This is a 2-phase study: PHASE I: In 1st phase of study, PK parameters were evaluated in total of 60 evaluable patients (30 patients per treatment group) Phase II was not conducted
Participant milestones
| Measure |
Tacrolimus Hexal®
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
38
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Tacrolimus Hexal®
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Graft loss
|
0
|
1
|
|
Overall Study
Surgical problems during nephrectomy
|
2
|
2
|
Baseline Characteristics
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Tacrolimus Hexal®
n=35 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=38 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to month 6Population: The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization
Change in Nankivell glomerular filtration rate (GFR) from baseline to 6 months Glomerular Filtration Rate (GFR): The GFR is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. Several studies have shown that in patients with progressive renal disease, GFR declines or reciprocal serum creatinine levels elevate linearly over time in a predictable manner. With the help of the serum creatinine values, the GFR was calculated via Nankivell formula.
Outcome measures
| Measure |
Tacrolimus Hexal®
n=24 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=27 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set)
|
47.65 mL/min
95% Confidence Interval 20.24 • Interval 41.7 to 53.6
|
38.60 mL/min
95% Confidence Interval 18.83 • Interval 31.32 to 45.89
|
PRIMARY outcome
Timeframe: end of month 1Compares the PK of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over one month period post transplantation vs. Prograf® in renal transplant patients
Outcome measures
| Measure |
Tacrolimus Hexal®
n=23 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=20 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1
Adjusted, log-transformed Estimates (ANOVA)
|
2.944 h/10^3*L
Interval 2.783 to 3.105
|
3.020 h/10^3*L
Interval 2.811 to 3.228
|
|
ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1
Adjusted, back-transformed Estimates (ANOVA)
|
18.991 h/10^3*L
Interval 16.163 to 22.314
|
20.484 h/10^3*L
Interval 16.63 to 25.231
|
SECONDARY outcome
Timeframe: baseline to month 12Population: The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization
The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation.
Outcome measures
| Measure |
Tacrolimus Hexal®
n=35 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=38 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)
Biopsy proven acute rejection (BPAR)
|
2 Incidences
Interval 0.7 to 19.16
|
3 Incidences
Interval 1.66 to 21.38
|
|
The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)
Graft loss
|
0 Incidences
Interval 0.0 to 10.0
|
1 Incidences
Interval 0.07 to 13.81
|
|
The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)
Death
|
0 Incidences
Interval 0.0 to 10.0
|
1 Incidences
Interval 0.07 to 13.81
|
|
The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)
Composite: BPAR, graft loss or death
|
2 Incidences
Interval 0.7 to 19.16
|
4 Incidences
Interval 2.94 to 24.8
|
SECONDARY outcome
Timeframe: baseline to Month 6Population: The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization
ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)\[ml/min\] without replacement of missing values
Outcome measures
| Measure |
Tacrolimus Hexal®
n=24 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=27 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation
|
48.33 mL/min
Standard Error 3.84
|
39.77 mL/min
Standard Error 4.61
|
SECONDARY outcome
Timeframe: least square (LS) mean change from baseline to Month 6MDRD GFR
Outcome measures
| Measure |
Tacrolimus Hexal®
n=35 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=38 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values
|
46.20 (ml/min)
Interval 37.62 to 54.79
|
38.52 (ml/min)
Interval 28.64 to 48.41
|
SECONDARY outcome
Timeframe: least square (LS) mean change from baseline to Month 6change in Cockcroft-Gault GFR
Outcome measures
| Measure |
Tacrolimus Hexal®
n=35 Participants
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf®
n=38 Participants
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values
|
60.45 (ml/min)
Interval 52.48 to 68.41
|
46.45 (ml/min)
Interval 36.89 to 56.02
|
Adverse Events
Tacrolimus Hexal
Serious events: 19 serious events
Other events: 34 other events
Deaths: 0 deaths
Prograf
Serious events: 17 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tacrolimus Hexal
n=35 participants at risk
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf
n=39 participants at risk
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Blood and lymphatic system disorders
THROMBOTIC MICROANGIOPATHY
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
COLITIS
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
PANCREATIC PSEUDOCYST
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
PANCREATITIS CHRONIC
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
IMPAIRED HEALING
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
IMPLANT SITE EXTRAVASATION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
OEDEMA PERIPHERAL
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
PYREXIA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
DIVERTICULITIS
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
ENTEROCOCCAL INFECTION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
HUMAN POLYOMAVIRUS INFECTION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
INFECTION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
LUNG INFECTION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
PERITONITIS
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
POLYOMAVIRUS-ASSOCIATED NEPHROPATHY
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
UROSEPSIS
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
ABDOMINAL WOUND DEHISCENCE
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
COMPLICATIONS OF TRANSPLANTED KIDNEY
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
DELAYED GRAFT FUNCTION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMOTHORAX
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Investigations
BLOOD CREATININE INCREASED
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
DYSURIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
FOCAL SEGMENTAL GLOMERULOSCLEROSIS
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
PROTEINURIA
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URETERAL NECROSIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URINARY TRACT DISORDER
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URINOMA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
Other adverse events
| Measure |
Tacrolimus Hexal
n=35 participants at risk
Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
Prograf
n=39 participants at risk
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
17.9%
7/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
17.9%
7/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Blood and lymphatic system disorders
NEPHROGENIC ANAEMIA
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
15.4%
6/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
12.8%
5/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
FLATULENCE
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
NAUSEA
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
12.8%
5/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
IMPAIRED HEALING
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
OEDEMA PERIPHERAL
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
17.9%
7/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
General disorders
PYREXIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
CYTOMEGALOVIRUS VIRAEMIA
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
SEPSIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
URINARY TRACT INFECTION
|
17.1%
6/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
41.0%
16/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
COMPLICATIONS OF TRANSPLANTED KIDNEY
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
28.2%
11/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
RENAL LYMPHOCELE
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
45.7%
16/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
48.7%
19/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Investigations
BLOOD CREATININE INCREASED
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
15.4%
6/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
25.7%
9/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
23.1%
9/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
2.9%
1/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
23.1%
9/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
17.9%
7/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
15.4%
6/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Nervous system disorders
HEADACHE
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Nervous system disorders
TREMOR
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Psychiatric disorders
INSOMNIA
|
11.4%
4/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
15.4%
6/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Psychiatric disorders
SLEEP DISORDER
|
8.6%
3/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
BLADDER PAIN
|
14.3%
5/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
7.7%
3/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
OLIGURIA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
RENAL HYPERTENSION
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
10.3%
4/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Renal and urinary disorders
URINARY RETENTION
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
2.6%
1/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Skin and subcutaneous tissue disorders
ACNE
|
5.7%
2/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
0.00%
0/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Skin and subcutaneous tissue disorders
SCAR PAIN
|
0.00%
0/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
5.1%
2/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
|
Vascular disorders
HYPERTENSION
|
34.3%
12/35
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
51.3%
20/39
One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
|
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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER