TriangleNCT02561962 · OUTCOME
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
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 of Cycle 1 to up to the end of Cycle 4, where each cycle is 3 weeks; up to 12 weeks.
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that occurred after receiving at least 1 dose of treatment. Treatment-related TEAEs were those considered related to study treatment by the investigator. Any clinically significant changes in ECGs, vital signs, physical examination with a neurologic assessment and clinical laboratory tests were recorded as TEAEs.
Analysis population: Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.
Groups in this outcome
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
| Group | Source count |
|---|---|
| Dose Exploration: AMG 224 Dose A | 3 |
| Dose Exploration: AMG 224 Dose B | 3 |
| Dose Exploration: AMG 224 Dose C | 3 |
| Dose Exploration: AMG 224 Dose D | 3 |
| Dose Exploration: AMG 224 Dose E | 6 |
| Dose Exploration: AMG 224 Dose F | 6 |
| Dose Exploration: AMG 224 Dose G | 5 |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 9 |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 2 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 2 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Exploration: AMG 224 Dose A | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose B | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose C | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose D | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose E | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose F | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Exploration: AMG 224 Dose G | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 1
- title
- Treatment-related TEAE
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that occurred after receiving at least 1 dose of treatment. Treatment-related TEAEs were those considered related to study treatment by the investigator. Any clinically significant changes in ECGs, vital signs, physical examination with a neurologic assessment and clinical laboratory tests were recorded as TEAEs.
- groups
- description
- Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG000
- title
- Dose Exploration: AMG 224 Dose A
- description
- Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG001
- title
- Dose Exploration: AMG 224 Dose B
- description
- Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG002
- title
- Dose Exploration: AMG 224 Dose C
- description
- Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG003
- title
- Dose Exploration: AMG 224 Dose D
- description
- Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG004
- title
- Dose Exploration: AMG 224 Dose E
- description
- Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG005
- title
- Dose Exploration: AMG 224 Dose F
- description
- Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG006
- title
- Dose Exploration: AMG 224 Dose G
- description
- Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG007
- title
- Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
- description
- Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- id
- OG008
- title
- Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 to up to the end of Cycle 4, where each cycle is 3 weeks; up to 12 weeks.
- title
- Number of Participants With a Treatment-emergent Adverse Event (TEAE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice