NCT03215030 · OUTCOME
Part 3: 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 20.5 months in Part 3
What was measured
Laboratory values included hematology, chemistry, and urinalysis as interpreted by the investigator.
Analysis population: FAS:all participants who took ≥1 dose,even if incomplete,of TAK-573 in Part 3 extension cohorts.However,clinically significant laboratory values data were not collected\&will never be available to present due to issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in report form,making data collection impossible.This issue did not impact participant safety/reliability of study data,particularly primary endpoint.
Groups in this outcome
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
| Group | Source count |
|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 0 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 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
- units
- Participants
- description
- Laboratory values included hematology, chemistry, and urinalysis as interpreted by the investigator.
- groups
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG000
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG001
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- population Description
- FAS:all participants who took ≥1 dose,even if incomplete,of TAK-573 in Part 3 extension cohorts.However,clinically significant laboratory values data were not collected\&will never be available to present due to issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in report form,making data collection impossible.This issue did not impact participant safety/reliability of study data,particularly primary endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 20.5 months in Part 3
- title
- Part 3: Percentage of Participants With Clinically Significant Laboratory Values
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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