Trial Outcomes & Findings for Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients (NCT NCT00183248)
NCT ID: NCT00183248
Last Updated: 2012-10-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
One year post kidney transplant
Results posted on
2012-10-02
Participant Flow
One center in the United States enrolled nine subjects who were recipients of living-related (1-haplotype-matched) donor kidney transplants between September 2004 and November 2006.
Participants underwent procedures at screening to establish inclusion/exclusion criteria.
Participant milestones
| Measure |
DBMCs
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
DBMCs
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Focal glomerulosclerosis proteinuria
|
1
|
0
|
Baseline Characteristics
Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
41.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year post kidney transplantPopulation: Intent-to-Treat
Outcome measures
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Overall Participant Survival at One Year Post Kidney Transplant
|
4 participants
|
5 participants
|
PRIMARY outcome
Timeframe: One year post kidney transplantPopulation: Intent-to-treat
Number of participants that did not experience kidney graft failure\[1\] at one year post-transplant \[1\]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation.
Outcome measures
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Overall Kidney Graft Survival at One Year Post-Transplant
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Three years post kidney transplantPopulation: Intent-to-Treat
Outcome measures
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Participant Survival at Three Years Post Kidney Transplant
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Three years post kidney transplantPopulation: Intent-to-Treat
Number of participants that did not experience kidney graft failure\[1\] at three years post-transplant \[1\]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation.
Outcome measures
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Graft Survival at Three Years Post-Transplant
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Three years post kidney transplantPopulation: Participants who experienced an acute rejection
Biopsy-proven acute renal (kidney) rejection\[1,2\]. 1. Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection\[2\] 2. Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999
Outcome measures
| Measure |
DBMCs
n=1 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=1 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Number of Kidney Biopsy-proven Acute Rejection
|
1 Rejection Events
|
1 Rejection Events
|
SECONDARY outcome
Timeframe: Three years post kidney transplantPopulation: Participants who experienced nephropathies
Number of chronic allograft nephropathies\[1,2,3\] at 3 years post kidney transplant. 1. Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater\[2\] with higher numeric scores indicating more severe nephropathy 2. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification\[3\] 3. Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999
Outcome measures
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=1 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Number of Chronic Allograft Nephropathies
|
6 Nephropathy Events
|
2 Nephropathy Events
|
SECONDARY outcome
Timeframe: Three years post kidney transplantPopulation: Intent-to-Treat
A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease.
Outcome measures
| Measure |
DBMCs
n=4 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 Participants
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Number of Graft-versus-host Disease (GVHD) Events
|
0 GVHD Events
|
0 GVHD Events
|
Adverse Events
DBMCs
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DBMCs
n=4 participants at risk
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 participants at risk
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Renal and urinary disorders
Nephrotic syndrome
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Chest pain
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Immune system disorders
Kidney transplant rejection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Tonsillitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Urinary tract infection
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Blood creatinine increased
|
75.0%
3/4 • Number of events 12
|
40.0%
2/5 • Number of events 2
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
Other adverse events
| Measure |
DBMCs
n=4 participants at risk
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
Control Group
n=5 participants at risk
Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
3/4 • Number of events 4
|
40.0%
2/5 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Cardiac disorders
Palpitations
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Eye disorders
Visual acuity reduced
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Palatal oedema
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Swollen tongue
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Face oedema
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Oedema peripheral
|
75.0%
3/4 • Number of events 4
|
0.00%
0/5
|
|
General disorders
Pain
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Body tinea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Fungal infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Gastroenteritis viral
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Herpes zoster
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Oral candidiasis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Oral herpes
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
2/4 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
75.0%
3/4 • Number of events 5
|
0.00%
0/5
|
|
Infections and infestations
Viral infection
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4
|
20.0%
1/5 • Number of events 3
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
25.0%
1/4 • Number of events 1
|
60.0%
3/5 • Number of events 3
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Platelet count increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Red blood cell count decreased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4
|
60.0%
3/5 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4
|
20.0%
1/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • Number of events 3
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
|
Renal and urinary disorders
Bladder spasm
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Renal and urinary disorders
Proteinuria
|
75.0%
3/4 • Number of events 4
|
40.0%
2/5 • Number of events 3
|
|
Reproductive system and breast disorders
Menorrhagia
|
25.0%
1/4 • Number of events 3
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Ovarian cyst
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Testicular pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar ulcer
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Acne
|
75.0%
3/4 • Number of events 3
|
60.0%
3/5 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
60.0%
3/5 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
50.0%
2/4 • Number of events 2
|
20.0%
1/5 • Number of events 2
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 3
|
80.0%
4/5 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place