TriangleNCT02171260 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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
- First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
What was measured
TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Analysis population: The SAS included all participants who received at least one dose of study drug.
Groups in this outcome
Part A1: Eribulin Mesylate 1.1 mg/m^2
Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
Part A1: Eribulin Mesylate 1.4 mg/m^2
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
Part A1: Eribulin Mesylate 1.8 mg/m^2
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
Part A1: Eribulin Mesylate PK Expansion
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
| Group | Source count |
|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 6 |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 6 |
| Part A1: Eribulin Mesylate 1.8 mg/m^2 | 5 |
| Part A1: Eribulin Mesylate PK Expansion | 5 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.8 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate PK Expansion | 5 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.8 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate PK Expansion | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
- groups
- description
- Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
- id
- OG000
- title
- Part A1: Eribulin Mesylate 1.1 mg/m^2
- description
- Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
- id
- OG001
- title
- Part A1: Eribulin Mesylate 1.4 mg/m^2
- description
- Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
- id
- OG002
- title
- Part A1: Eribulin Mesylate 1.8 mg/m^2
- description
- Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
- id
- OG003
- title
- Part A1: Eribulin Mesylate PK Expansion
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The SAS included all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice