TriangleNCT02953340 · OUTCOME
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
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
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
What was measured
FN was defined as an oral temperature \>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \[°F\]) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
Analysis population: ITT population included all participants who were randomized.
Groups in this outcome
(Arm 1): SPI-2012 and TC
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
(Arm 2): Pegfilgrastim and TC
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
| Group | Source count |
|---|---|
| (Arm 1): SPI-2012 and TC | 118 |
| (Arm 2): Pegfilgrastim and TC | 119 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (Arm 1): SPI-2012 and TC | 1 | Not reported | Not reported | Not reported | Not reported |
| (Arm 2): Pegfilgrastim and TC | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 119
- units
- Participants
- description
- FN was defined as an oral temperature \>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \[°F\]) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
- groups
- description
- At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
- id
- OG000
- title
- (Arm 1): SPI-2012 and TC
- description
- At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
- id
- OG001
- title
- (Arm 2): Pegfilgrastim and TC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ITT population included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
- title
- Number of Participants With Febrile Neutropenia (FN) in Cycle 1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice