TriangleNCT04145531 · OUTCOME
Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 2 weeks
What was measured
Blood samples were collected for serum asparaginase activity level determination.
Analysis population: Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set.
Groups in this outcome
Part A: JZP-458 IM 25 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
| Group | Source count |
|---|---|
| Part A: JZP-458 IM 25 mg/m^2 (MWF) | 32 |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 49 |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 59 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: JZP-458 IM 25 mg/m^2 (MWF) | 31 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 82 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 47 | Not reported | Not reported | Not reported | Not reported |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 53 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 82
- group Id
- OG002
- value
- 47
- group Id
- OG003
- value
- 53
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 49
- group Id
- OG003
- value
- 59
- units
- Participants
- description
- Blood samples were collected for serum asparaginase activity level determination.
- groups
- description
- Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
- id
- OG000
- title
- Part A: JZP-458 IM 25 mg/m^2 (MWF)
- description
- Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
- id
- OG001
- title
- Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
- description
- Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
- id
- OG002
- title
- Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
- description
- Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
- id
- OG003
- title
- Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set.
- reporting Status
- POSTED
- time Frame
- Baseline up to 2 weeks
- title
- Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice