NCT03687125 · OUTCOME
Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Renal 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
- millimoles per liter (mmol/L)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day -1), Day 100
What was measured
Clinical serum chemistry tests included renal function parameters i.e. creatinine and bilirubin. Change from baseline in clinical serum chemistry tests i.e. renal 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
Creatinine: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 3 |
|---|
| Tinostamustine 220 mg/m^2 | 3 |
|---|
Values in millimoles per liter (mmol/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | 14.1440 | 18.71075 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | 25.6360 | 8.43282 | Not reported | Not reported | Not reported |
|---|
Bilirubin: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 3 |
|---|
| Tinostamustine 220 mg/m^2 | 3 |
|---|
Values in millimoles per liter (mmol/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | -1.710 | 3.4200 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | -3.420 | 6.1655 | Not reported | Not reported | Not reported |
|---|
Direct Bilirubin: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 2 |
|---|
| Tinostamustine 220 mg/m^2 | 1 |
|---|
Values in millimoles per liter (mmol/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | 0.855 | 1.2092 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | -3.420 | NA | Not reported | Not reported | NA indicates that standard deviation was not estimated for single participant. |
|---|
Indirect Bilirubin: Change at Day 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine 180 mg/m^2 | 2 |
|---|
| Tinostamustine 220 mg/m^2 | 1 |
|---|
Values in millimoles per liter (mmol/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine 180 mg/m^2 | 0.855 | 1.2092 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine 220 mg/m^2 | -6.840 | NA | Not reported | Not reported | NA indicates that standard deviation was not estimated for single participant. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.71075
- value
- 14.1440
- group Id
- OG001
- spread
- 8.43282
- value
- 25.6360
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Creatinine: Change at Day 100
- categories
- measurements
- group Id
- OG000
- spread
- 3.4200
- value
- -1.710
- group Id
- OG001
- spread
- 6.1655
- value
- -3.420
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Bilirubin: Change at Day 100
- categories
- measurements
- group Id
- OG000
- spread
- 1.2092
- value
- 0.855
- comment
- NA indicates that standard deviation was not estimated for single participant.
- group Id
- OG001
- spread
- NA
- value
- -3.420
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Direct Bilirubin: Change at Day 100
- categories
- measurements
- group Id
- OG000
- spread
- 1.2092
- value
- 0.855
- comment
- NA indicates that standard deviation was not estimated for single participant.
- group Id
- OG001
- spread
- NA
- value
- -6.840
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Indirect Bilirubin: Change at Day 100
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Clinical serum chemistry tests included renal function parameters i.e. creatinine and bilirubin. Change from baseline in clinical serum chemistry tests i.e. renal 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: Renal Function Parameters
- type
- SECONDARY
- unit Of Measure
- millimoles per liter (mmol/L)
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