TriangleNCT05209152 · OUTCOME
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
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
- Day 1 to day 28 of cycle 1 (each cycle was 28 days)
What was measured
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to AMG 176: Grade 3 or higher non-hematological or a Grade 4 hematologic adverse event (AE) during the DLT observation period in Part 1. CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.
Analysis population: DLT-evaluable participants were those who experienced a DLT during the DLT evaluation period or if they received 75% of the planned doses of AMG 176 and completed the DLT evaluation period.
Groups in this outcome
Part 1A Dose Exploration: AMG 176 Dose Level 1
Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2
Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 4 |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to AMG 176: Grade 3 or higher non-hematological or a Grade 4 hematologic adverse event (AE) during the DLT observation period in Part 1. CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.
- groups
- description
- Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Part 1A Dose Exploration: AMG 176 Dose Level 1
- description
- Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-evaluable participants were those who experienced a DLT during the DLT evaluation period or if they received 75% of the planned doses of AMG 176 and completed the DLT evaluation period.
- reporting Status
- POSTED
- time Frame
- Day 1 to day 28 of cycle 1 (each cycle was 28 days)
- title
- Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice