TriangleNCT03465540 · OUTCOME
Number of Participants Who Experienced 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
- Up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b)
What was measured
A TEAE was defined as any AE starting on or after the first dose of investigational product. Any clinically significant changes in vital signs, physical examinations, electrocardiogram (ECGs) and clinical laboratory test results were recorded as AEs. The grading and severity of adverse events were based on the guidelines provided in the CTCAE version 4.03. Treatment-related TEAEs were any events that the investigator assessed as related to AMG 397.
Analysis population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
Groups in this outcome
Part 1a: 80 mg AMG 397
Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1a: 160 mg AMG 397
Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1a: 320 mg AMG 397
Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 80 mg AMG 397
Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 160 mg AMG 397
Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 320 mg AMG 397
Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
| Group | Source count |
|---|---|
| Part 1a: 80 mg AMG 397 | 2 |
| Part 1a: 160 mg AMG 397 | 6 |
| Part 1a: 320 mg AMG 397 | 4 |
| Part 1b: 80 mg AMG 397 | 4 |
| Part 1b: 160 mg AMG 397 | 5 |
| Part 1b: 320 mg AMG 397 | 3 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1a: 80 mg AMG 397 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1a: 160 mg AMG 397 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1a: 320 mg AMG 397 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1b: 80 mg AMG 397 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1b: 160 mg AMG 397 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1b: 320 mg AMG 397 | 3 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1a: 80 mg AMG 397 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1a: 160 mg AMG 397 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1a: 320 mg AMG 397 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1b: 80 mg AMG 397 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1b: 160 mg AMG 397 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1b: 320 mg AMG 397 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- title
- Treatment-related TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- A TEAE was defined as any AE starting on or after the first dose of investigational product. Any clinically significant changes in vital signs, physical examinations, electrocardiogram (ECGs) and clinical laboratory test results were recorded as AEs. The grading and severity of adverse events were based on the guidelines provided in the CTCAE version 4.03. Treatment-related TEAEs were any events that the investigator assessed as related to AMG 397.
- groups
- description
- Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG000
- title
- Part 1a: 80 mg AMG 397
- description
- Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG001
- title
- Part 1a: 160 mg AMG 397
- description
- Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG002
- title
- Part 1a: 320 mg AMG 397
- description
- Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG003
- title
- Part 1b: 80 mg AMG 397
- description
- Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG004
- title
- Part 1b: 160 mg AMG 397
- description
- Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG005
- title
- Part 1b: 320 mg AMG 397
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
- reporting Status
- POSTED
- time Frame
- Up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b)
- title
- Number of Participants Who Experienced 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