TriangleNCT03398200 · OUTCOME
Percentage of Participants With Progressive Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 1 year
What was measured
A progressive response is defined as follows: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be \> 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder Anyone who did not have a progressive response was considered as progression free survival.
Groups in this outcome
Hyperbaric Oxygen Therapy
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
No Hyperbaric Oxygen Therapy
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
| Group | Source count |
|---|---|
| Hyperbaric Oxygen Therapy | 52 |
| No Hyperbaric Oxygen Therapy | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | 91.3 | Not reported | 78.2 | 96.7 | Not reported |
| No Hyperbaric Oxygen Therapy | 92.6 | Not reported | 78.6 | 97.6 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.76
- statistical Comment
- 1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.76
- statistical Comment
- 1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.2
- upper Limit
- 96.7
- value
- 91.3
- group Id
- OG001
- lower Limit
- 78.6
- upper Limit
- 97.6
- value
- 92.6
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- units
- Participants
- description
- A progressive response is defined as follows: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be \> 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder Anyone who did not have a progressive response was considered as progression free survival.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
- id
- OG000
- title
- Hyperbaric Oxygen Therapy
- description
- Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
- id
- OG001
- title
- No Hyperbaric Oxygen Therapy
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Percentage of Participants With Progressive Free Survival
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice