Trial Outcomes & Findings for Desensitization in Kidney Transplantation (NCT NCT00908583)
NCT ID: NCT00908583
Last Updated: 2016-04-01
Results Overview
Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
1 year post baseline
Results posted on
2016-04-01
Participant Flow
Subjects could be enrolled in multiple study phases. Enrollment in phases 1-2 was an adaptive approach and was fixed a priori in Phases 3-5. The adaptive approach was based on treatment effect (immunodominant antibody (iAb) reduction).
44 subjects received 52 treatments in this study. 7 subjects were enrolled in multiple phases. Four patients received treatment in two study phases (two patients were enrolled in Phases 1 and 2, one patient was enrolled in study Phases 1 and 3, and one patient was enrolled in Phases 2 and 3). One patient was enrolled in Phases 1, 2 and 4.
Participant milestones
| Measure |
All Study Participants
Combined study participants all phases.
|
|---|---|
|
Phase 1
STARTED
|
20
|
|
Phase 1
COMPLETED
|
15
|
|
Phase 1
NOT COMPLETED
|
5
|
|
Phase 2
STARTED
|
12
|
|
Phase 2
COMPLETED
|
10
|
|
Phase 2
NOT COMPLETED
|
2
|
|
Phase 3
STARTED
|
10
|
|
Phase 3
COMPLETED
|
8
|
|
Phase 3
NOT COMPLETED
|
2
|
|
Phase 4
STARTED
|
5
|
|
Phase 4
COMPLETED
|
3
|
|
Phase 4
NOT COMPLETED
|
2
|
|
Phase 5
STARTED
|
5
|
|
Phase 5
COMPLETED
|
2
|
|
Phase 5
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Study Participants
Combined study participants all phases.
|
|---|---|
|
Phase 1
Withdrawal by Subject
|
1
|
|
Phase 1
Adverse Event
|
4
|
|
Phase 2
Physician Decision
|
1
|
|
Phase 2
Adverse Event
|
1
|
|
Phase 3
Adverse Event
|
2
|
|
Phase 4
Adverse Event
|
1
|
|
Phase 4
Physician Decision
|
1
|
|
Phase 5
Adverse Event
|
3
|
Baseline Characteristics
Desensitization in Kidney Transplantation
Baseline characteristics by cohort
| Measure |
All Study Participants
n=44 Participants
Combined study participants, all phases.
|
|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 year post baselineNumber of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted
Outcome measures
| Measure |
Phase 1, Cycle 1
n=44 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 1 Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2, Cycle 1
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2 Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 1
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 4, Single Stage
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 5, Single Stage
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
|---|---|---|---|---|---|---|---|---|
|
Number of Living Donor Transplant Candidates That Are Transplanted
|
19 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Day 62Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD).
Outcome measures
| Measure |
Phase 1, Cycle 1
n=19 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 1 Cycle 2
n=16 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2, Cycle 1
n=11 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2 Cycle 2
n=10 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 1
n=10 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 2
n=8 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 4, Single Stage
n=4 Participants
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 5, Single Stage
n=5 Participants
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
|---|---|---|---|---|---|---|---|---|
|
Overall Safety of Bortezomib
Incidence of CTCAE Grade 3 Anemia (<8.0-6.5 g/dL)
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Overall Safety of Bortezomib
Incidence of CTCAE Grade 4 Anemia (<6.5g/dL)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of CTCAE Grade 3 Thrombocytopenia
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of CTCAE Grade 4 Thrombocytopenia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of CTCAE Grade 3 Neutropenia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of CTCAE Grade 4 Neutropenia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of new onset level 1 PN
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Overall Safety of Bortezomib
Incidence of new onset level 2 PN
|
5 participants
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of new onset level 3 PN
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of new onset level 4 PN
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Incidence of new onset level 5 PN
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
CMV D+/R- Status
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
CMV Viremia or Invasive Disease
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Polyomavirus Allograft Nephropathy (PVN)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Safety of Bortezomib
Malignancy
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 46 daysNumber of patients on the waiting list whose cytotoxic PRA is decreased by 50%.
Outcome measures
| Measure |
Phase 1, Cycle 1
n=44 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 1 Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2, Cycle 1
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2 Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 1
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 4, Single Stage
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 5, Single Stage
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: One graft loss occurred due to graft thrombosis within 24 hours (due to unrecognized hypercoagulability disorder without AMR). Two patients were transplanted at other centers and data was not available. This dropped the number of analyzed patients to 16 from 19.
Acute rejection rate at 6 months of all desensitized and transplanted patients
Outcome measures
| Measure |
Phase 1, Cycle 1
n=16 Participants
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 1 Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2, Cycle 1
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2 Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 1
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3, Cycle 2
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 4, Single Stage
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 5, Single Stage
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
|---|---|---|---|---|---|---|---|---|
|
Acute Rejection Rate
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1, Two Stages
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2, Two Stages
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 3
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 4, Single Stage
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 5, Single Stage
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1, Two Stages
n=20 participants at risk
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2, Two Stages
n=12 participants at risk
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3
n=10 participants at risk
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 4, Single Stage
n=5 participants at risk
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 5, Single Stage
n=5 participants at risk
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Generalized Weakness
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Hepatobiliary disorders
Pancreatitis
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Hepatobiliary disorders
Elevated Liver Function Test
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Cardiac disorders
Chest Pain
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Seizure
|
10.0%
2/20 • Number of events 2 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
40.0%
2/5 • Number of events 2 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
Hypoxemia
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Nervous system disorders
Peripheral Neuropathy
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/20 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Eye disorders
Blurred Vision
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
Headache
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
Endocrine disorders
Diarrhea
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Perivascular Dermatitis
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
General disorders
Facial Weakness
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Phase 1, Two Stages
n=20 participants at risk
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 2, Two Stages
n=12 participants at risk
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 3
n=10 participants at risk
Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 4, Single Stage
n=5 participants at risk
Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
Phase 5, Single Stage
n=5 participants at risk
Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • 1 year
|
16.7%
2/12 • Number of events 2 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/20 • 1 year
|
16.7%
2/12 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Nervous system disorders
Peripheral Sensory Neuropathy (PN)
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Foot Infection
|
0.00%
0/20 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Upper Respiratory Viral Infection
|
0.00%
0/20 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Cardiac disorders
Cardiopulomonary Instability
|
0.00%
0/20 • 1 year
|
0.00%
0/12 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place