TriangleNCT03386513 · OUTCOME
Dose Escalation Phase: 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
- Up to approximately 81 months
What was measured
An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
Analysis population: The safety population included all participants who received at least 1 dose of study drug.
Groups in this outcome
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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.
Dose Escalation - 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 |
|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 3 |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 12 |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 13 |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 7 |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 5 |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 2 |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 3 |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 6 |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 14 |
Reported measurements
All TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 12 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 13 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 14 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 14
- title
- All TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 11
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 14
- units
- Participants
- description
- An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
- 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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
- Dose Escalation - 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.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- Dose Escalation Phase: 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 · Independent clinical review pending · Not medical advice