TriangleNCT05209152 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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 cycle 1 to 30 days after the last dose of AMG 176 or end of study, whichever occurred earlier (cycle length = 28 days). Median treatment duration was 2.7 months
What was measured
An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, and clinical laboratory tests were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Analysis population: The full analysis set included all enrolled participants who received at least 1 dose of AMG 176.
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
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 3 | Not reported | Not reported | Not reported | Not reported |
Any serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Any serious TEAE
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, and clinical laboratory tests were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
- 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
- The full analysis set included all enrolled participants who received at least 1 dose of AMG 176.
- reporting Status
- POSTED
- time Frame
- Day 1 cycle 1 to 30 days after the last dose of AMG 176 or end of study, whichever occurred earlier (cycle length = 28 days). Median treatment duration was 2.7 months
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice