TriangleNCT05590377 · OUTCOME
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity
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
- Phase 1: Up to 15.9 months
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTCAE Version 5.0.
Analysis population: The Safety Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug.
Groups in this outcome
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.
| Group | Source count |
|---|---|
| Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab | 3 |
| Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab | 6 |
| Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab | 6 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab | 3 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTCAE Version 5.0.
- groups
- description
- Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.
- id
- OG000
- title
- Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.
- id
- OG001
- title
- Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.
- id
- OG002
- title
- Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug.
- reporting Status
- POSTED
- time Frame
- Phase 1: Up to 15.9 months
- title
- Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice