TriangleNCT04306900 · OUTCOME
The Incident of Adverse Events
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
- Through study completion, an average of 1 year
What was measured
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Analysis population: This set included all participants who received at least 1 dose or any partial dose of study treatment. The Safety Analysis Set was used for safety endpoints and study treatment administration.
Groups in this outcome
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
| Group | Source count |
|---|---|
| Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6) | 8 |
| Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6) | 44 |
| Cohort 12 - Gastric (Budigalimab + mFOLFOX6) | 25 |
| Cohort 3A - Gastric (TTX-030 + mFOLFOX6) | 6 |
| Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel) | 7 |
| Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel) | 28 |
| Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel) | 17 |
| Cohort 4 - CRC (TTX-030 + Budigalimab) | 14 |
| Cohort 6 - HNSCC (TTX-030 + Budigalimab) | 5 |
| Cohort 8 - GEC (TTX-030 + Budigalimab) | 23 |
| Cohort 10 - UCC (TTX-030 + Pembrolizumab) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6) | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6) | 44 | Not reported | Not reported | Not reported | Not reported |
| Cohort 12 - Gastric (Budigalimab + mFOLFOX6) | 25 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3A - Gastric (TTX-030 + mFOLFOX6) | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel) | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel) | 28 | Not reported | Not reported | Not reported | Not reported |
| Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel) | 17 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - CRC (TTX-030 + Budigalimab) | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6 - HNSCC (TTX-030 + Budigalimab) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 8 - GEC (TTX-030 + Budigalimab) | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 10 - UCC (TTX-030 + Pembrolizumab) | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 28
- group Id
- OG006
- value
- 17
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 23
- group Id
- OG010
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 28
- group Id
- OG006
- value
- 17
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 23
- group Id
- OG010
- value
- 8
- units
- Participants
- description
- Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
- groups
- description
- Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
- id
- OG000
- title
- Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
- description
- Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
- id
- OG001
- title
- Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
- description
- Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
- id
- OG002
- title
- Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
- description
- Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
- id
- OG003
- title
- Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
- description
- Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
- id
- OG004
- title
- Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
- description
- Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
- id
- OG005
- title
- Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
- description
- Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
- id
- OG006
- title
- Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
- description
- Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
- id
- OG007
- title
- Cohort 4 - CRC (TTX-030 + Budigalimab)
- description
- Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
- id
- OG008
- title
- Cohort 6 - HNSCC (TTX-030 + Budigalimab)
- description
- Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
- id
- OG009
- title
- Cohort 8 - GEC (TTX-030 + Budigalimab)
- description
- Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
- id
- OG010
- title
- Cohort 10 - UCC (TTX-030 + Pembrolizumab)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- This set included all participants who received at least 1 dose or any partial dose of study treatment. The Safety Analysis Set was used for safety endpoints and study treatment administration.
- reporting Status
- POSTED
- time Frame
- Through study completion, an average of 1 year
- title
- The Incident of Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice