TriangleNCT03386513 · OUTCOME
Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit
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
- Up to approximately 81 months
Analysis population: The safety population included all participants who received at least 1 dose of study drug. ADA data were collected and reported per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Groups in this outcome
Schedule A: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.09 mg/kg
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.18 mg/kg
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.3 mg/kg
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.45 mg/kg
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule B: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Schedule B: IMGN632 0.03 mg/kg
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Schedule B: IMGN632 0.06 mg/kg
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 3 |
| Schedule A: IMGN632 0.045 mg/kg | 111 |
| Schedule A: IMGN632 0.09 mg/kg | 19 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 4 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 3 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.045 mg/kg | 22 | Not reported | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.18 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.45 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.06 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 111
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 10
- units
- Participants
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG006
- title
- Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG007
- title
- Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG008
- title
- Schedule B: IMGN632 0.06 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all participants who received at least 1 dose of study drug. ADA data were collected and reported per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice