TriangleNCT01761240 · 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 (Up to approximately 2 years 7 months)
What was measured
Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.
Analysis population: The safety analysis set was the group of participants who received at least 1 dose of study drug.
Groups in this outcome
MORAb-066 0.1 mg/kg
Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 0.3 mg/kg
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 1 mg/kg
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 2 mg/kg
Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 3 mg/kg
Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
| Group | Source count |
|---|---|
| MORAb-066 0.1 mg/kg | 3 |
| MORAb-066 0.3 mg/kg | 4 |
| MORAb-066 1 mg/kg | 5 |
| MORAb-066 2 mg/kg | 7 |
| MORAb-066 3 mg/kg | 8 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.1 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 0.3 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 1 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 2 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 3 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.1 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 1 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 2 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| MORAb-066 3 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- units
- Participants
- description
- Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.
- groups
- description
- Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG000
- title
- MORAb-066 0.1 mg/kg
- description
- Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG001
- title
- MORAb-066 0.3 mg/kg
- description
- Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG002
- title
- MORAb-066 1 mg/kg
- description
- Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG003
- title
- MORAb-066 2 mg/kg
- description
- Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG004
- title
- MORAb-066 3 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set was the group of participants who received at least 1 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 (Up to approximately 2 years 7 months)
- 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-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice