TriangleNCT01871727 · OUTCOME
Lead-In Part and Main Study Part: 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
- From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months)
What was measured
TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.
Analysis population: Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg.
Groups in this outcome
Lead-In Part: E7777 6 mcg/kg
Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 12 mcg/kg
Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 15 mcg/kg
Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part and Main Study Part: E7777 9 mcg/kg
Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 2 |
| Lead-In Part: E7777 12 mcg/kg | 9 |
| Lead-In Part: E7777 15 mcg/kg | 2 |
| Lead-In Part and Main Study Part: E7777 9 mcg/kg | 98 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part and Main Study Part: E7777 9 mcg/kg | 97 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Lead-In Part and Main Study Part: E7777 9 mcg/kg | 36 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 97
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 36
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 98
- units
- Participants
- description
- TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.
- groups
- description
- Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG000
- title
- Lead-In Part: E7777 6 mcg/kg
- description
- Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG001
- title
- Lead-In Part: E7777 12 mcg/kg
- description
- Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG002
- title
- Lead-In Part: E7777 15 mcg/kg
- description
- Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
- id
- OG003
- title
- Lead-In Part and Main Study Part: E7777 9 mcg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months)
- title
- Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice