Trial Outcomes & Findings for Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant (NCT NCT03330795)
NCT ID: NCT03330795
Last Updated: 2025-07-22
Results Overview
How many, if any, participants die during study participation.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Average of approximately 31 months for those who received an initial transplant
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
BOLT-BMT Protocol
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
BOLT-BMT Protocol
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
No longer eligible to receive transplants or study interventions due to medical contraindication
|
1
|
Baseline Characteristics
Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant
Baseline characteristics by cohort
| Measure |
BOLT-BMT Protocol
n=5 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
Primary Immunodeficiency
B-cell disorder (e.g. CVID)
|
2 Participants
n=5 Participants
|
|
Primary Immunodeficiency
T-cell lymphopenia/T-cell disorder (SCID, CID)
|
2 Participants
n=5 Participants
|
|
Primary Immunodeficiency
Myeloid disorder (e.g. CGD)
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average of approximately 31 months for those who received an initial transplantPopulation: This Number of Participants analyzed includes one participant who became ineligible: no longer eligible to receive transplants or study interventions due to medical contraindication. One participant was terminated from the study prior to receiving a study transplant, prior to developing fatal illness, because this patient developed an infection which made her ineligible to proceed to transplant. This participant died during follow-up of safety events on study after termination from the study.
How many, if any, participants die during study participation.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=5 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Safety: Death
|
4 Participants
|
PRIMARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
How many, if any, participants develop engraftment syndrome.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Safety: Engraftment Syndrome
|
0 Participants
|
PRIMARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Engraftment Failure
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1 Participants
|
PRIMARY outcome
Timeframe: Average of ~25 months.Population: All participants
Outcome measures
| Measure |
BOLT-BMT Protocol
n=5 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Grade 4 or 5 Events Potentially Attributable to Rituximab
|
4 Participants
|
PRIMARY outcome
Timeframe: throughout the first year post BOLTPopulation: Recipients of CD3/CD19-depleted marrow (includes 1 participant receiving BMT \>1 year post BOLT)
Diagnosis of BOS (Bronchiolitis Obliterans Syndrome) at any time up to 1 year post BOLT. BOS is one of the undesirable complications of lung transplantation.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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BOS at 1 Year Post BOLT
|
0 Participants
|
PRIMARY outcome
Timeframe: at 1 Year Post Lung Transplant (BOLT)Population: Recipients of CD3/CD19-depleted marrow (includes 1 participant receiving BMT \>1 year post BOLT)
The number of participant(s) who need either supplemental oxygen and/or ventilator support (noninvasive/invasive) will be assessed using the Bronchiolitis Obliterans Syndrome (BOS) Classification Score for pulmonary function (e.g., the Forced Expiratory Volume in 1 Second (FEV1). FEV1 is air volume exhaled in 1 second during spirometry, a lung function test. (Continuing dependence on supplemental oxygen or ventilatory support is an undesirable outcome of lung transplantation).
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Efficacy: Count of Participants With Requirement for Supplemental Oxygen and/or Ventilatory Support
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 Year Post Bone Marrow Transplant (BMT)Population: Recipients of CD3/CD19-depleted marrow
The number of participants who have ≥ 25% donor T-cell chimerism.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Efficacy: Count of Participants With T-cell Chimerism
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 Year Post Bone Marrow Transplant (BMT)Population: Recipients of CD3/CD19-depleted marrow
The number of participants with myeloid disorders (e.g. Chronic Granulomatous Disease \[CGD\]) who attain ≥ 10% myeloid chimerism.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=1 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Efficacy: Count of Participants With Myeloid Chimerism
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 Year Post Bone Marrow Transplant (BMT)Population: Recipients of CD3/CD19-depleted marrow
The number of participants with B-cell disorders who attain ≥ 10% B-cell chimerism.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=2 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Efficacy: Count of Participants B-cell Chimerism
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 Months Post Lung Transplant (BOLT)Population: Recipients of a bilateral lung transplant
The number of participants for which it is feasible to proceed to BMT within 6 months following lung transplant.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=4 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Count of Participants Able to Proceed to BMT
|
1 Participants
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SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
The number of participants who develop tolerance to both the host and pulmonary graft. Definition of tolerance: A participant's successful withdrawal from systemic immunosuppression for 6 weeks with no increase cGVHD score and stable or improving PFTs.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Count of Participants Who Achieve Tolerance
|
0 Participants
|
SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
Summary of long-term complications of combined solid organ and bone marrow transplant (BMT).
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Long Term Complications of Combined Solid Organ and Bone Marrow Transplant
|
0 Participants
|
SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
The number of participants who develop acute cellular rejection and graft failure post BMT.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Count of Participants Who Develop Acute Cellular Rejection and Graft Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year following BMTPopulation: Recipients of CD3/CD19-depleted marrow
The number of participants who are able to start immunosuppression withdrawal.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Count of Participants Able to Initiate Withdrawal of Immunosuppression
|
0 Participants
|
SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: None of the participants withdrew from IS during study participation.
Time from BMT to withdrawal of immunosuppression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: None of the participants achieved independence from treatment dose antimicrobial drugs during study participation.
A measure of pathogen-specific immunity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year post BMTPopulation: Recipients of CD3/CD19-depleted marrow
For participants with immune deficiencies with T cell lymphopenias, number of participants achieving age adjusted, low limit normal range lymphocyte count by 1-year post-BMT.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=2 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Post-BMT Achievement of Normal Lymphocyte Count for T-cell Lymphopenias
|
0 Participants
|
SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
The number of participants who develop acute graft-versus-host disease (GVHD) following tandem BOLT and BMT.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Count of Participants Who Develop Acute Graft-Versus-Host Disease (GVHD)
|
1 Participants
|
SECONDARY outcome
Timeframe: Average of ~7.5 months of time post BMT for those receiving both lung and BMT transplants.Population: Recipients of CD3/CD19-depleted marrow
The number of participants who develop chronic graft-versus-host disease (GVHD) following tandem BOLT and BMT.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=3 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
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Count of Participants With Chronic Graft-Versus-Host Disease (GVHD)
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 2 years post BOLTPopulation: Recipients of a bilateral lung transplant
A significant development in chronic lung allograft dysfunction (as evidenced by a change in BOS stage) or allograft failure at 1 year and up to 2 year post lung transplant (for lung transplant alone and BOLT-BMT subjects.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=4 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
|
Count of Participants Who Develop Chronic Lung Allograft Dysfunction or Allograft Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: Average of approximately 9 months.Population: All participants, prior to the start of BMT Conditioning
The number of Grade 4 or 5 adverse events possibly related to the use of rituximab prior to the start of BMT conditioning.
Outcome measures
| Measure |
BOLT-BMT Protocol
n=5 Participants
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
|
|---|---|
|
Count of Pre-BMT Conditioning Rituximab Related Adverse Events
|
3 Participants
|
Adverse Events
BOLT-BMT Protocol
Serious events: 5 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
BOLT-BMT Protocol
n=5 participants at risk
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
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|---|---|
|
Immune system disorders
Acute graft versus host disease in intestine
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Renal and urinary disorders
Acute kidney injury
|
60.0%
3/5 • Number of events 7 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Bone marrow disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Colitis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
General disorders
Feeling abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Fluid balance positive
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Fungal sepsis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Infections and infestations
Infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Vascular disorders
Jugular vein thrombosis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Nervous system disorders
Meningitis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Myocardial infarction
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Ear and labyrinth disorders
Otitis externa
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Respiratory failure
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Vascular disorders
Septic shock
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
Other adverse events
| Measure |
BOLT-BMT Protocol
n=5 participants at risk
Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Abdominal distension
|
40.0%
2/5 • Number of events 6 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Abnormal faeces
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Acid base balance abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Acidosis
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Immune system disorders
Acute graft versus host disease in skin
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Renal and urinary disorders
Acute kidney injury
|
40.0%
2/5 • Number of events 7 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Administration related reaction
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Alkalosis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Anaemia
|
80.0%
4/5 • Number of events 6 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Anorectal discomfort
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Psychiatric disorders
Anxiety
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Appetite disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Hepatobiliary disorders
Ascites
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Infections and infestations
Aspergillus infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Aspergillus test positive
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Infections and infestations
Bacteraemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
BK virus infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood albumin decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • Number of events 3 • Average of approximately 25 months
|
|
Investigations
Blood bilirubin increased
|
40.0%
2/5 • Number of events 4 • Average of approximately 25 months
|
|
Investigations
Blood calcium decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood count abnormal
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Blood creatinine increased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Blood disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood electrolytes decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood electrolytes increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood fibrinogen decreased
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Blood immunoglobulin A decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood immunoglobulin G decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood magnesium decreased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Blood magnesium increased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Blood parathyroid hormone increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood phosphorus decreased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Blood potassium decreased
|
20.0%
1/5 • Number of events 3 • Average of approximately 25 months
|
|
Investigations
Blood potassium increased
|
60.0%
3/5 • Number of events 5 • Average of approximately 25 months
|
|
Investigations
Blood pressure decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood test abnormal
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Blood triglycerides increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Blood urea increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Bloody discharge
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Body tinea
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Brain natriuretic peptide increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Breath sounds abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
C-reactive protein increased
|
20.0%
1/5 • Number of events 3 • Average of approximately 25 months
|
|
Infections and infestations
Candida infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Vascular disorders
Cardiogenic shock
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Cardiomyopathy
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Cardiovascular symptom
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
CD4 lymphocytes decreased
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Vascular disorders
Cerebrovascular disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Chest X-ray abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Clostridium difficile infection
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Psychiatric disorders
Cognitive disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Complication associated with device
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Compression fracture
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Conduction disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Psychiatric disorders
Confusional state
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
3/5 • Number of events 5 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Cutaneous symptom
|
40.0%
2/5 • Number of events 5 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Dental caries
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm muscle weakness
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
5/5 • Number of events 13 • Average of approximately 25 months
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Endocarditis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Enterococcal bacteraemia
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Infections and infestations
Enterovirus infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Enzyme level increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
40.0%
2/5 • Number of events 4 • Average of approximately 25 months
|
|
Vascular disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Epstein-Barr viraemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Fibrin D dimer increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Fluid balance negative
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Fluid balance positive
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Flushing
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Fungal infection
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Investigations
Gamma-glutamyltransferase decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Gastroenteritis norovirus
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Gastrointestinal disorder
|
40.0%
2/5 • Number of events 5 • Average of approximately 25 months
|
|
General disorders
Gastrointestinal inflammation
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Gastrointestinal viral infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
General symptom
|
40.0%
2/5 • Number of events 4 • Average of approximately 25 months
|
|
Investigations
Glucose urine present
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Haematochezia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Vascular disorders
Haematoma
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Renal and urinary disorders
Haematuria
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Investigations
Haemoglobin decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Psychiatric disorders
Hallucination
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Investigations
Hepatic enzyme increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Hepatobiliary disorders
Hyperammonaemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Endocrine disorders
Hyperglycaemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
5/5 • Number of events 5 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
80.0%
4/5 • Number of events 5 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Hyperprothrombinaemia
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Vascular disorders
Hypertension
|
80.0%
4/5 • Number of events 7 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
80.0%
4/5 • Number of events 6 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Vascular disorders
Hypotension
|
80.0%
4/5 • Number of events 5 • Average of approximately 25 months
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Ileus paralytic
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Incontinence
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
International normalised ratio increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Investigation abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Hepatobiliary disorders
Jaundice
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Laboratory test abnormal
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
80.0%
4/5 • Number of events 5 • Average of approximately 25 months
|
|
Investigations
Liver function test abnormal
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Investigations
Liver function test decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Liver function test increased
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
General disorders
Localised oedema
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Lower respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Lymphocyte count decreased
|
80.0%
4/5 • Number of events 7 • Average of approximately 25 months
|
|
Vascular disorders
Lymphoedema
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Malabsorption
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Injury, poisoning and procedural complications
Medical device site pain
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Monocyte count decreased
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Investigations
Monocyte count increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Mucosal infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Muscle injury
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
40.0%
2/5 • Number of events 4 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Mycobacterial infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Number of events 10 • Average of approximately 25 months
|
|
Investigations
Neutrophil count decreased
|
60.0%
3/5 • Number of events 5 • Average of approximately 25 months
|
|
Investigations
Neutrophil count increased
|
80.0%
4/5 • Number of events 4 • Average of approximately 25 months
|
|
Hepatobiliary disorders
Nodular regenerative hyperplasia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Non-cardiac chest pain
|
80.0%
4/5 • Number of events 4 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Nonspecific reaction
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Occult blood positive
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Oedema
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Reproductive system and breast disorders
Oedema genital
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Oedema peripheral
|
80.0%
4/5 • Number of events 4 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Renal and urinary disorders
Oliguria
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Oral candidiasis
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Oral disorder
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Ear and labyrinth disorders
Otitis externa
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Pain
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Pericarditis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Petechiae
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Platelet count decreased
|
60.0%
3/5 • Number of events 7 • Average of approximately 25 months
|
|
Investigations
Platelet count increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
100.0%
5/5 • Number of events 6 • Average of approximately 25 months
|
|
Psychiatric disorders
Postoperative delirium
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Proctalgia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Protein-losing gastroenteropathy
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Protein total decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Protein urine
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Protein urine present
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Pulmonary function test decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
60.0%
3/5 • Number of events 4 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Renal and urinary disorders
Renal cyst
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Metabolism and nutrition disorders
Respiratory acidosis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
60.0%
3/5 • Number of events 5 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Infections and infestations
Respiratory tract infection viral
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Reticulocyte count decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Right ventricular systolic pressure increased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Nervous system disorders
Seizure
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Skin bacterial infection
|
20.0%
1/5 • Number of events 2 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
20.0%
1/5 • Number of events 3 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Nervous system disorders
Somnolence
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
Spinal compression fracture
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Sputum culture positive
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Infections and infestations
Staphylococcal infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Psychiatric disorders
Suicidal ideation
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
General disorders
Temperature regulation disorder
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
2/5 • Number of events 3 • Average of approximately 25 months
|
|
Nervous system disorders
Tremor
|
60.0%
3/5 • Number of events 3 • Average of approximately 25 months
|
|
Investigations
Ultrasound liver abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Ultrasound scan abnormal
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
Urinary casts present
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
40.0%
2/5 • Number of events 2 • Average of approximately 25 months
|
|
Infections and infestations
Viral infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
4/5 • Number of events 6 • Average of approximately 25 months
|
|
Investigations
Weight decreased
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Surgical and medical procedures
Weight loss diet
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
|
Investigations
White blood cell count decreased
|
80.0%
4/5 • Number of events 8 • Average of approximately 25 months
|
|
Infections and infestations
Wound infection
|
20.0%
1/5 • Number of events 1 • Average of approximately 25 months
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 240-669-5064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place