NCT03687125 · OUTCOME
Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Liver Function Parameters
Tinostamustine Conditioning and Autologous Stem Cell · Source last updated 2021-06-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units per liter (U/L)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day -1), Day 100
What was measured
Clinical serum chemistry tests included liver function parameters i.e. Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase, (AST) and Lactate dehydrogenase. Change from baseline in clinical serum chemistry tests i.e. liver function parameters at Day 100 were reported.
Analysis population: Safety population included all participants who received tinostamustine. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2. Here, number analyzed refers to the number of participants with available data for each specified category.
Groups in this outcome
Tinostamustine 180 mg/m^2
Participants received single dose of tinostamustine 180 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
Tinostamustine 220 mg/m^2
Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 3 |
|---|
| Tinostamustine 220 mg/m^2 | 3 |
|---|
Reported measurements
ALT: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 3 |
|---|
| Tinostamustine 220 mg/m^2 | 3 |
|---|
Values in units per liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | 4.0 | 1.73 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | 0.3 | 3.06 | Not reported | Not reported | Not reported |
|---|
ALP: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 3 |
|---|
| Tinostamustine 220 mg/m^2 | 3 |
|---|
Values in units per liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | 10.7 | 6.81 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | 14.7 | 5.13 | Not reported | Not reported | Not reported |
|---|
AST: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 3 |
|---|
| Tinostamustine 220 mg/m^2 | 3 |
|---|
Values in units per liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | 3.0 | 1.00 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | 2.0 | 4.36 | Not reported | Not reported | Not reported |
|---|
Lactate dehydrogenase: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 2 |
|---|
| Tinostamustine 220 mg/m^2 | 2 |
|---|
Values in units per liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | -21.0 | 11.31 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | 4.0 | 2.83 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.73
- value
- 4.0
- group Id
- OG001
- spread
- 3.06
- value
- 0.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- ALT: Change at Day 100
- categories
- measurements
- group Id
- OG000
- spread
- 6.81
- value
- 10.7
- group Id
- OG001
- spread
- 5.13
- value
- 14.7
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- ALP: Change at Day 100
- categories
- measurements
- group Id
- OG000
- spread
- 1.00
- value
- 3.0
- group Id
- OG001
- spread
- 4.36
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- AST: Change at Day 100
- categories
- measurements
- group Id
- OG000
- spread
- 11.31
- value
- -21.0
- group Id
- OG001
- spread
- 2.83
- value
- 4.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Lactate dehydrogenase: Change at Day 100
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Clinical serum chemistry tests included liver function parameters i.e. Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase, (AST) and Lactate dehydrogenase. Change from baseline in clinical serum chemistry tests i.e. liver function parameters at Day 100 were reported.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received single dose of tinostamustine 180 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
- id
- OG000
- title
- Tinostamustine 180 mg/m^2
- description
- Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
- id
- OG001
- title
- Tinostamustine 220 mg/m^2
- param Type
- MEAN
- population Description
- Safety population included all participants who received tinostamustine. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2. Here, number analyzed refers to the number of participants with available data for each specified category.
- reporting Status
- POSTED
- time Frame
- Baseline (Day -1), Day 100
- title
- Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Liver Function Parameters
- type
- SECONDARY
- unit Of Measure
- units per liter (U/L)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle