TriangleNCT03215030 · OUTCOME
Part 1: Percentage of Participants With Clinically Significant Laboratory Values
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 54.3 months in Part 1
What was measured
Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.
Analysis population: SAS:all participants who took ≥1 dose,even if incomplete,of TAK-573.However,clinically significant laboratory values data were not collected \& will never be available to present due to an issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in the report form,making data collection impossible.This issue did not impact participant safety or reliability of study data,particularly primary endpoint.
Groups in this outcome
Part 1 (Dose Escalation) Schedule A
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule C
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A | 0 |
| Part 1 (Dose Escalation) Schedule B | 0 |
| Part 1 (Dose Escalation) Schedule C | 0 |
| Part 1 (Dose Escalation) Schedule D | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.
- groups
- description
- Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 1 (Dose Escalation) Schedule A
- description
- Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 1 (Dose Escalation) Schedule B
- description
- Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 1 (Dose Escalation) Schedule C
- description
- Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 1 (Dose Escalation) Schedule D
- population Description
- SAS:all participants who took ≥1 dose,even if incomplete,of TAK-573.However,clinically significant laboratory values data were not collected \& will never be available to present due to an issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in the report form,making data collection impossible.This issue did not impact participant safety or reliability of study data,particularly primary endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 54.3 months in Part 1
- title
- Part 1: Percentage of Participants With Clinically Significant Laboratory Values
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice