TriangleNCT05047536 · OUTCOME
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 20 months
What was measured
Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
Analysis population: All participants who received at least 1 dose of study treatment (KZR-261).
Groups in this outcome
Dose 1
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 2
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 3
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 4
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 5
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 6
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 7
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 8
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 9
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Melanoma Expansion Cohort
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
| Group | Source count |
|---|---|
| Dose 1 | 2 |
| Dose 2 | 2 |
| Dose 3 | 2 |
| Dose 4 | 6 |
| Dose 5 | 6 |
| Dose 6 | 6 |
| Dose 7 | 5 |
| Dose 8 | 17 |
| Dose 9 | 8 |
| Melanoma Expansion Cohort | 7 |
Reported measurements
Mild (Grade 1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Moderate (Grade 2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
Severe (Grade 3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 2 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Life-threatening (Grade 4)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 12 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 5 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
Death (Grade 5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Mild (Grade 1)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- title
- Moderate (Grade 2)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- title
- Severe (Grade 3)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 5
- title
- Life-threatening (Grade 4)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Death (Grade 5)
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 7
- units
- Participants
- description
- Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
- groups
- description
- Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG000
- title
- Dose 1
- description
- Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG001
- title
- Dose 2
- description
- Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG002
- title
- Dose 3
- description
- Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG003
- title
- Dose 4
- description
- Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG004
- title
- Dose 5
- description
- Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG005
- title
- Dose 6
- description
- Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG006
- title
- Dose 7
- description
- Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG007
- title
- Dose 8
- description
- Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG008
- title
- Dose 9
- description
- Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG009
- title
- Melanoma Expansion Cohort
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of study treatment (KZR-261).
- reporting Status
- POSTED
- time Frame
- 20 months
- title
- Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice