TriangleNCT02573259 · OUTCOME
Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
What was measured
DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
Analysis population: DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.
Groups in this outcome
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
Part 1: PF-06801591 1 mg/kg (IV)
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
Part 1: PF-06801591 3 mg/kg (IV)
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
Part 1: PF-06801591 10 mg/kg (IV)
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
| Group | Source count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
| Part 1: PF-06801591 1 mg/kg (IV) | 8 |
| Part 1: PF-06801591 3 mg/kg (IV) | 8 |
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 1 mg/kg (IV) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 3 mg/kg (IV) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 10 mg/kg (IV) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 15
- units
- Participants
- description
- DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
- groups
- description
- Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
- id
- OG000
- title
- Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
- description
- Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
- id
- OG001
- title
- Part 1: PF-06801591 1 mg/kg (IV)
- description
- Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
- id
- OG002
- title
- Part 1: PF-06801591 3 mg/kg (IV)
- description
- Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
- id
- OG003
- title
- Part 1: PF-06801591 10 mg/kg (IV)
- description
- Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
- id
- OG004
- title
- Part 1: PF-06801591 300 mg (Subcutaneously [SC])
- param Type
- NUMBER
- population Description
- DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.
- reporting Status
- POSTED
- time Frame
- Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
- title
- Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice