TriangleNCT03439280 · OUTCOME
Phase 1: Number of Participants With TEAEs Leading to Treatment Discontinuation
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
- From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)
What was measured
TEAEs leading to discontinuation were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug leading to discontinuation of any of the study treatment when given in combination.
Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Groups in this outcome
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 4 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 3 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 12 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 22 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 3 |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- TEAEs leading to discontinuation were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug leading to discontinuation of any of the study treatment when given in combination.
- groups
- description
- Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG000
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
- description
- Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG001
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
- description
- Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG002
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
- description
- Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG003
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
- description
- Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG004
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
- description
- Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
- id
- OG005
- title
- Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)
- title
- Phase 1: Number of Participants With TEAEs Leading to Treatment Discontinuation
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice