TriangleNCT04145531 · OUTCOME
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
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
- Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months
What was measured
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Analysis population: Safety events were assessed in the Safety 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) | 33 |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 51 |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: JZP-458 IM 25 mg/m^2 (MWF) | 32 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 | Not reported | Not reported | Not reported | Not reported |
| Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 49 | Not reported | Not reported | Not reported | Not reported |
| Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 60 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 49
- group Id
- OG003
- value
- 60
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 51
- group Id
- OG003
- value
- 61
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
- 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
- Safety events were assessed in the Safety Analysis Set.
- reporting Status
- POSTED
- time Frame
- Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months
- title
- Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice