TriangleNCT03735680 · OUTCOME
Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
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
- 28 days
What was measured
Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.
Groups in this outcome
Part 1, Cohort A
Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
Part 1, Cohort B
Patients were administered a single IV infusion of OMN-100 at a dose of 3 mg/kg.
Part 1, Cohort E
Patients were administered a single IV infusion of OMN-100 at a dose of 2 mg/kg.
Part 2, Group 2
Patients were administered a single IV infusion of ONM-100 at a dose of 3 mg/kg.
Part 2, Group 3
Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
Part 3
Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
| Group | Source count |
|---|---|
| Part 1, Cohort A | 3 |
| Part 1, Cohort B | 3 |
| Part 1, Cohort E | 3 |
| Part 2, Group 2 | 4 |
| Part 2, Group 3 | 6 |
| Part 3 | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort A | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort B | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort E | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 3 | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 11
- units
- Participants
- description
- Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.
- groups
- description
- Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
- id
- OG000
- title
- Part 1, Cohort A
- description
- Patients were administered a single IV infusion of OMN-100 at a dose of 3 mg/kg.
- id
- OG001
- title
- Part 1, Cohort B
- description
- Patients were administered a single IV infusion of OMN-100 at a dose of 2 mg/kg.
- id
- OG002
- title
- Part 1, Cohort E
- description
- Patients were administered a single IV infusion of ONM-100 at a dose of 3 mg/kg.
- id
- OG003
- title
- Part 2, Group 2
- description
- Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
- id
- OG004
- title
- Part 2, Group 3
- description
- Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
- id
- OG005
- title
- Part 3
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice