TriangleNCT03582033 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A
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
- From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
What was measured
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Groups in this outcome
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
| Group | Source count |
|---|---|
| Part A: SEA-BCMA 100mg | 2 |
| Part A: SEA-BCMA 200mg | 2 |
| Part A: SEA-BCMA 400mg | 2 |
| Part A: SEA-BCMA 800mg | 7 |
| Part A: SEA-BCMA 1600mg | 22 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 20 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 8 | Not reported | Not reported | Not reported | Not reported |
Treatment Related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 13 | Not reported | Not reported | Not reported | Not reported |
TEAEs (>= Grade 3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 200mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 400mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 800mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A: SEA-BCMA 1600mg | 13 | 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
- 2
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 20
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 8
- title
- TESAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 13
- title
- Treatment Related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 13
- title
- TEAEs (>= Grade 3)
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 22
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
- groups
- description
- Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG000
- title
- Part A: SEA-BCMA 100mg
- description
- Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG001
- title
- Part A: SEA-BCMA 200mg
- description
- Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG002
- title
- Part A: SEA-BCMA 400mg
- description
- Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG003
- title
- Part A: SEA-BCMA 800mg
- description
- Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG004
- title
- Part A: SEA-BCMA 1600mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
- reporting Status
- POSTED
- time Frame
- From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice