Trial Outcomes & Findings for Study Evaluating Rapamune® Maintenance Regimen (NCT NCT00478608)
NCT ID: NCT00478608
Last Updated: 2010-04-28
Results Overview
The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
79 participants
Primary outcome timeframe
6 months after transplantation
Results posted on
2010-04-28
Participant Flow
Patients were recruited in Korea from March 2007 to November 2007.
Patients were screened up to 7 days.
Participant milestones
| Measure |
Sirolimus (SRL)
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Sirolimus (SRL)
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Serious Adverse Event
|
14
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
3
|
Baseline Characteristics
Study Evaluating Rapamune® Maintenance Regimen
Baseline characteristics by cohort
| Measure |
Sirolimus (SRL)
n=79 Participants
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Age Continuous
|
40.16 years
STANDARD_DEVIATION 12.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after transplantationPopulation: Patients who received at least one dosing of SRL after transplantation.
The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
Outcome measures
| Measure |
Sirolimus (SRL)
n=79 Participants
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.
|
12 patients
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Patients who received at least one dose of SRL after transplantation. Observed values
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR \<15 is consistent with kidney failure.
Outcome measures
| Measure |
Sirolimus (SRL)
n=79 Participants
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Glomerular Filtration Rate (GFR) (Nankivell Method)
6 months
|
67.36 mL/min
Standard Deviation 15.25
|
|
Glomerular Filtration Rate (GFR) (Nankivell Method)
12 months
|
71.92 mL/min
Standard Deviation 18.82
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 monthsPopulation: Patients who received at least one dose of SRL after transplantation. Observed values
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.
Outcome measures
| Measure |
Sirolimus (SRL)
n=79 Participants
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Serum Creatinine
Baseline
|
9.42 mg/dl
Standard Deviation 3.64
|
|
Serum Creatinine
6 months
|
1.30 mg/dl
Standard Deviation 0.36
|
|
Serum Creatinine
12 months
|
1.25 mg/dl
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients who received at least one dosing of SRL after transplantation.
Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 weeks), retransplant or death during the first 12 months after randomization.
Outcome measures
| Measure |
Sirolimus (SRL)
n=79 Participants
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Patient and Graft Survival
Patient survival 6 months
|
77 patients
|
|
Patient and Graft Survival
Patient survival 12 months
|
76 patients
|
|
Patient and Graft Survival
Graft survival 6 months
|
77 patients
|
|
Patient and Graft Survival
Graft survival 12 months
|
76 patients
|
SECONDARY outcome
Timeframe: 12 months after transplantationPopulation: Patients who received at least one dosing of SRL after transplantation.
The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
Outcome measures
| Measure |
Sirolimus (SRL)
n=79 Participants
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation
|
15 patients
|
Adverse Events
Sirolimus (SRL)
Serious events: 39 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sirolimus (SRL)
n=79 participants at risk
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Infections and infestations
Herpes zoster
|
7.6%
6/79
|
|
Infections and infestations
Pneumonia
|
6.3%
5/79
|
|
Infections and infestations
Gastroenteritis
|
2.5%
2/79
|
|
Infections and infestations
Urinary tract infection
|
2.5%
2/79
|
|
Infections and infestations
Varicella
|
1.3%
1/79
|
|
Infections and infestations
Parotitis
|
1.3%
1/79
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.3%
1/79
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/79
|
|
Infections and infestations
Fungal infection
|
1.3%
1/79
|
|
Infections and infestations
Cellulitis
|
1.3%
1/79
|
|
Investigations
Blood creatinine increased
|
12.7%
10/79
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/79
|
|
Investigations
Blood glucose increased
|
1.3%
1/79
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/79
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
3/79
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/79
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.3%
1/79
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
1/79
|
|
Gastrointestinal disorders
Haematochezia
|
1.3%
1/79
|
|
Gastrointestinal disorders
Faecaloma
|
1.3%
1/79
|
|
Vascular disorders
Lymphocele
|
7.6%
6/79
|
|
General disorders
Pyrexia
|
2.5%
2/79
|
|
General disorders
Oedema peripheral
|
1.3%
1/79
|
|
General disorders
Oedema
|
1.3%
1/79
|
|
General disorders
Asthenia
|
1.3%
1/79
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.3%
1/79
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/79
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
1.3%
1/79
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/79
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
1/79
|
|
Cardiac disorders
Myocarditis
|
1.3%
1/79
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
1.3%
1/79
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/79
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
2/79
|
|
Renal and urinary disorders
Urinary incontinence
|
1.3%
1/79
|
|
Renal and urinary disorders
Renal mass
|
1.3%
1/79
|
|
Injury, poisoning and procedural complications
Seroma
|
1.3%
1/79
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.3%
1/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
1.3%
1/79
|
|
General disorders
Death
|
3.8%
3/79
|
Other adverse events
| Measure |
Sirolimus (SRL)
n=79 participants at risk
Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
5.1%
4/79
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/79
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/79
|
|
Gastrointestinal disorders
Constipation
|
39.2%
31/79
|
|
Gastrointestinal disorders
Diarrhoea
|
26.6%
21/79
|
|
Gastrointestinal disorders
Nausea
|
20.3%
16/79
|
|
Gastrointestinal disorders
Mouth ulceration
|
17.7%
14/79
|
|
Gastrointestinal disorders
Vomiting
|
16.5%
13/79
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
12/79
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
8/79
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.9%
7/79
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.3%
5/79
|
|
Gastrointestinal disorders
Stomatitis
|
6.3%
5/79
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
4/79
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
2.5%
2/79
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.3%
1/79
|
|
Gastrointestinal disorders
Haematemesis
|
1.3%
1/79
|
|
Gastrointestinal disorders
Oral disorder
|
1.3%
1/79
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.3%
1/79
|
|
Gastrointestinal disorders
Oral discomfort
|
1.3%
1/79
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.3%
1/79
|
|
Gastrointestinal disorders
Dental caries
|
1.3%
1/79
|
|
Gastrointestinal disorders
Anorectal disorder
|
1.3%
1/79
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.3%
1/79
|
|
Investigations
Blood cholesterol increased
|
36.7%
29/79
|
|
Investigations
Alanine aminotransferase increased
|
21.5%
17/79
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
12/79
|
|
Investigations
Urine output decreased
|
13.9%
11/79
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.7%
10/79
|
|
Investigations
Blood creatinine increased
|
11.4%
9/79
|
|
Investigations
Hepatic enzyme increased
|
11.4%
9/79
|
|
Investigations
Blood triglycerides increased
|
10.1%
8/79
|
|
Investigations
Blood glucose increased
|
10.1%
8/79
|
|
Investigations
Weight increased
|
6.3%
5/79
|
|
Investigations
Blood pressure increased
|
5.1%
4/79
|
|
Investigations
Blood phosphorus decreased
|
3.8%
3/79
|
|
Investigations
Haemoglobin decreased
|
3.8%
3/79
|
|
Investigations
Blood albumin decreased
|
3.8%
3/79
|
|
Investigations
Blood potassium increased
|
2.5%
2/79
|
|
Investigations
Blood uric acid increased
|
2.5%
2/79
|
|
Investigations
Body temperature increased
|
1.3%
1/79
|
|
Investigations
Platelet count decreased
|
1.3%
1/79
|
|
Investigations
Blood potassium decreased
|
1.3%
1/79
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
1/79
|
|
Investigations
Blood calcium decreased
|
1.3%
1/79
|
|
Investigations
Blood alkaline phosphatase increased
|
1.3%
1/79
|
|
Investigations
Blood calcium increased
|
1.3%
1/79
|
|
Investigations
White blood cells urine positive
|
1.3%
1/79
|
|
Investigations
White blood cell count decreased
|
1.3%
1/79
|
|
Infections and infestations
Upper respiratory tract infection
|
32.9%
26/79
|
|
Infections and infestations
Nasopharyngitis
|
15.2%
12/79
|
|
Infections and infestations
Urinary tract infection
|
7.6%
6/79
|
|
Infections and infestations
Herpes zoster
|
7.6%
6/79
|
|
Infections and infestations
Herpes simplex
|
5.1%
4/79
|
|
Infections and infestations
Rhinitis
|
2.5%
2/79
|
|
Infections and infestations
Oral candidiasis
|
2.5%
2/79
|
|
Infections and infestations
Tinea versicolour
|
2.5%
2/79
|
|
Infections and infestations
Tinea pedis
|
2.5%
2/79
|
|
Infections and infestations
Varicella
|
1.3%
1/79
|
|
Infections and infestations
Vaginal infection
|
1.3%
1/79
|
|
Infections and infestations
Tinea cruris
|
1.3%
1/79
|
|
Infections and infestations
Folliculitis
|
1.3%
1/79
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/79
|
|
Infections and infestations
BK virus infection
|
1.3%
1/79
|
|
Infections and infestations
Infection
|
1.3%
1/79
|
|
Infections and infestations
Skin infection
|
1.3%
1/79
|
|
Infections and infestations
Rash pustular
|
1.3%
1/79
|
|
Infections and infestations
Gingival infection
|
1.3%
1/79
|
|
Infections and infestations
Fungal infection
|
1.3%
1/79
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/79
|
|
Infections and infestations
Orchitis
|
1.3%
1/79
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
24.1%
19/79
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
15.2%
12/79
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.1%
8/79
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.6%
6/79
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.3%
5/79
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.3%
5/79
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.1%
4/79
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.5%
2/79
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
2/79
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.5%
2/79
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.3%
1/79
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.3%
1/79
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
1/79
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
1.3%
1/79
|
|
General disorders
Pyrexia
|
10.1%
8/79
|
|
General disorders
Chest discomfort
|
8.9%
7/79
|
|
General disorders
Oedema peripheral
|
7.6%
6/79
|
|
General disorders
Generalised oedema
|
6.3%
5/79
|
|
General disorders
Oedema
|
6.3%
5/79
|
|
General disorders
Pitting oedema
|
2.5%
2/79
|
|
General disorders
Face oedema
|
2.5%
2/79
|
|
General disorders
Chest pain
|
2.5%
2/79
|
|
General disorders
Catheter site pain
|
1.3%
1/79
|
|
General disorders
Mass
|
1.3%
1/79
|
|
General disorders
Influenza like illness
|
1.3%
1/79
|
|
General disorders
Swelling
|
1.3%
1/79
|
|
General disorders
Sense of oppression
|
1.3%
1/79
|
|
General disorders
Xerosis
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Acne
|
22.8%
18/79
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
10/79
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.9%
7/79
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.5%
2/79
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.3%
1/79
|
|
Injury, poisoning and procedural complications
Procedural pain
|
30.4%
24/79
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.5%
2/79
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
1.3%
1/79
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.3%
1/79
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.3%
1/79
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.9%
11/79
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
6/79
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
3/79
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
3/79
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
2/79
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.5%
2/79
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
1/79
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.3%
1/79
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
1/79
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.3%
1/79
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
1/79
|
|
Nervous system disorders
Headache
|
19.0%
15/79
|
|
Nervous system disorders
Convulsion
|
3.8%
3/79
|
|
Nervous system disorders
Dizziness
|
2.5%
2/79
|
|
Nervous system disorders
Paraesthesia
|
2.5%
2/79
|
|
Nervous system disorders
Tremor
|
2.5%
2/79
|
|
Nervous system disorders
Neuropathy peripheral
|
1.3%
1/79
|
|
Nervous system disorders
Neuralgia
|
1.3%
1/79
|
|
Nervous system disorders
Migraine
|
1.3%
1/79
|
|
Nervous system disorders
Somnolence
|
1.3%
1/79
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
1/79
|
|
Nervous system disorders
Dysarthria
|
1.3%
1/79
|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
19/79
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
1/79
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.1%
8/79
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.9%
7/79
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
6/79
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
3/79
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.5%
2/79
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.3%
1/79
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.3%
1/79
|
|
Psychiatric disorders
Insomnia
|
15.2%
12/79
|
|
Psychiatric disorders
Sleep disorder
|
2.5%
2/79
|
|
Renal and urinary disorders
Haematuria
|
8.9%
7/79
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
3/79
|
|
Renal and urinary disorders
Azotaemia
|
2.5%
2/79
|
|
Renal and urinary disorders
Albuminuria
|
1.3%
1/79
|
|
Renal and urinary disorders
Pollakiuria
|
1.3%
1/79
|
|
Renal and urinary disorders
Renal tubular necrosis
|
1.3%
1/79
|
|
Reproductive system and breast disorders
Amenorrhoea
|
5.1%
4/79
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.5%
2/79
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.5%
2/79
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.3%
1/79
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.3%
1/79
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
1.3%
1/79
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.3%
1/79
|
|
Eye disorders
Visual disturbance
|
2.5%
2/79
|
|
Eye disorders
Vision blurred
|
1.3%
1/79
|
|
Eye disorders
Xerophthalmia
|
1.3%
1/79
|
|
Eye disorders
Ocular hyperaemia
|
1.3%
1/79
|
|
Eye disorders
Conjunctivitis
|
1.3%
1/79
|
|
Eye disorders
Dry eye
|
1.3%
1/79
|
|
Eye disorders
Eyelid oedema
|
1.3%
1/79
|
|
Eye disorders
Conjunctival oedema
|
1.3%
1/79
|
|
Vascular disorders
Hypertension
|
7.6%
6/79
|
|
Vascular disorders
Lymphocele
|
1.3%
1/79
|
|
Cardiac disorders
Arrhythmia
|
2.5%
2/79
|
|
Cardiac disorders
Palpitations
|
1.3%
1/79
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/79
|
|
Cardiac disorders
Angina pectoris
|
1.3%
1/79
|
|
Endocrine disorders
Hyperthyroidism
|
2.5%
2/79
|
|
Endocrine disorders
Cushingoid
|
2.5%
2/79
|
|
Hepatobiliary disorders
Hepatitis
|
2.5%
2/79
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.3%
1/79
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.3%
1/79
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.3%
1/79
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/79
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER