Trial Outcomes & Findings for Allogeneic Transplantation For Severe Osteopetrosis (NCT NCT00775931)
NCT ID: NCT00775931
Last Updated: 2019-07-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Day 100
Results posted on
2019-07-31
Participant Flow
Participant milestones
| Measure |
Marrow Graft Transplant Conditioning
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Transplantation For Severe Osteopetrosis
Baseline characteristics by cohort
| Measure |
Marrow Graft Transplant Conditioning
n=6 Participants
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 Participants
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 100Outcome measures
| Measure |
Marrow Graft Transplant Conditioning
n=6 Participants
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 Participants
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
Number of Patients Who Achieved Donor Cell Engraftment
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 100Outcome measures
| Measure |
Marrow Graft Transplant Conditioning
n=6 Participants
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 Participants
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
Transplant Related Mortality at 100 Days
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 100 post transplantOutcome measures
| Measure |
Marrow Graft Transplant Conditioning
n=6 Participants
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 Participants
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
Transplant Related Toxicity
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: by Day 100 after transplantOutcome measures
| Measure |
Marrow Graft Transplant Conditioning
n=6 Participants
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 Participants
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
Incidence of Grade II - IV Acute Graft-versus-host Disease
|
2 Participants
|
0 Participants
|
Adverse Events
Marrow Graft Transplant Conditioning
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Cord Blood Transplant Conditioning
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Marrow Graft Transplant Conditioning
n=6 participants at risk
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 participants at risk
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
General disorders
Multi-Organ Failure
|
16.7%
1/6
|
0.00%
0/1
|
|
Cardiac disorders
Myocarditis
|
16.7%
1/6
|
0.00%
0/1
|
|
General disorders
Acute Graft versus Host Disease
|
16.7%
1/6
|
0.00%
0/1
|
Other adverse events
| Measure |
Marrow Graft Transplant Conditioning
n=6 participants at risk
Pre-transplant conditioning using Campath-1H, Busulfan, Fludarabine monophosphate, and total lymphoid irradiation followed by unrelated or matched related donor marrow graft transplantation (both peripheral blood and marrow) and a second CD34 cell infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Total Lymphoid Irradiation: Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Fludarabine monophosphate: Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
|
Cord Blood Transplant Conditioning
n=1 participants at risk
Pre-transplant conditioning using Campath-1H, Busulfan and Cyclophosphamide followed by unrelated umbilical cord blood transplantation and a second smaller portion cord blood graft infusion on Day 42.
Campath-1H: Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
Busulfan: patients\<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
Cyclophosphamide: Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving
|
|---|---|---|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
16.7%
1/6
|
100.0%
1/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Reactive Airway Disease
|
16.7%
1/6
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal Failure
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
33.3%
2/6
|
0.00%
0/1
|
|
Nervous system disorders
Seizure
|
16.7%
1/6
|
0.00%
0/1
|
|
Gastrointestinal disorders
Small Bowel Ascites
|
0.00%
0/6
|
100.0%
1/1
|
|
Eye disorders
Subconjunctival Hemorrhages
|
16.7%
1/6
|
0.00%
0/1
|
|
Infections and infestations
Upper Respiratory Infection
|
16.7%
1/6
|
0.00%
0/1
|
|
Infections and infestations
Viral Infection, Blood
|
33.3%
2/6
|
100.0%
1/1
|
|
Infections and infestations
Viral Infection, Myocardium
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
33.3%
2/6
|
0.00%
0/1
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/6
|
100.0%
1/1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Autoimmune Hemolytic Anemia
|
16.7%
1/6
|
0.00%
0/1
|
|
Infections and infestations
Bacterial Infection, Blood
|
66.7%
4/6
|
0.00%
0/1
|
|
Infections and infestations
Bacterial Infection, Respiratory
|
16.7%
1/6
|
100.0%
1/1
|
|
Infections and infestations
Bacterial Infection, Feces
|
16.7%
1/6
|
100.0%
1/1
|
|
Vascular disorders
Capillary Leak
|
16.7%
1/6
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Blood Clot in Bladder Wall
|
0.00%
0/6
|
100.0%
1/1
|
|
Renal and urinary disorders
Requires Continuous Veno-Venous Hemofiltration, NOS
|
16.7%
1/6
|
0.00%
0/1
|
|
Infections and infestations
Cystitis
|
33.3%
2/6
|
0.00%
0/1
|
|
Cardiac disorders
Complete Heart Block
|
16.7%
1/6
|
0.00%
0/1
|
|
Infections and infestations
Fungal Infection, Blood
|
33.3%
2/6
|
0.00%
0/1
|
|
Infections and infestations
Fungal Infection, Respiratory
|
50.0%
3/6
|
100.0%
1/1
|
|
Infections and infestations
Fungal Infection, Feces
|
0.00%
0/6
|
100.0%
1/1
|
|
Infections and infestations
Fungal Infection, Urine
|
16.7%
1/6
|
0.00%
0/1
|
|
Nervous system disorders
Further Decompression of Lateral and Third Ventricles
|
16.7%
1/6
|
0.00%
0/1
|
|
Renal and urinary disorders
Requires Hemodialysis, NOS
|
16.7%
1/6
|
100.0%
1/1
|
|
Vascular disorders
Hypertension
|
16.7%
1/6
|
0.00%
0/1
|
|
Renal and urinary disorders
Hyperechogenic Renomegaly with Ascites
|
0.00%
0/6
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6
|
0.00%
0/1
|
|
Nervous system disorders
Intracranial Hemorrhage
|
16.7%
1/6
|
0.00%
0/1
|
|
Nervous system disorders
Intraparenchymal Bleed
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Requires Intubation, NOS
|
83.3%
5/6
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Large Splenic Infarct
|
0.00%
0/6
|
100.0%
1/1
|
|
Infections and infestations
Sinus Infection
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Low Lung Volumes
|
0.00%
0/6
|
100.0%
1/1
|
|
Vascular disorders
Obstruction of Left Proximal Internal Jugular Vein
|
16.7%
1/6
|
0.00%
0/1
|
|
Eye disorders
Papilledema and Retinal Hemorrhages Leading to Blindness
|
16.7%
1/6
|
0.00%
0/1
|
|
Gastrointestinal disorders
Partial Small Bowel Obstruction
|
16.7%
1/6
|
0.00%
0/1
|
|
Cardiac disorders
Pericardial Effusion
|
83.3%
5/6
|
100.0%
1/1
|
|
Cardiac disorders
Placement of Epicardial Ventricular Pacing Wire
|
16.7%
1/6
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
83.3%
5/6
|
100.0%
1/1
|
Additional Information
Dr. Paul Orchard
Masonic Cancer Center, University of Minnesota
Phone: 612-626-2313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place