TriangleNCT03269136 · OUTCOME
Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
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 (maximum up to of 32.3 months)
What was measured
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
Analysis population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Groups in this outcome
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
| Group | Source count |
|---|---|
| Part 2A: PF-06863135 SC | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
- groups
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG000
- title
- Part 2A: PF-06863135 SC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
- 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 (maximum up to of 32.3 months)
- title
- Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice