TriangleNCT02643420 · OUTCOME
Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of planned dose
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1 to 4 (each cycle was 21 days)
What was measured
RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.
Analysis population: Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population.
Groups in this outcome
Arm 1: SPI-2012 and TC
Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
Arm 2: Pegfilgrastim and TC
Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
| Group | Source count |
|---|---|
| Arm 1: SPI-2012 and TC | 197 |
| Arm 2: Pegfilgrastim and TC | 208 |
Reported measurements
Docetaxel
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: SPI-2012 and TC | 99.1 | 5.47 | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC | 98.1 | 8.45 | Not reported | Not reported | Not reported |
Cyclophosphamide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: SPI-2012 and TC | 99.3 | 3.86 | Not reported | Not reported | Not reported |
| Arm 2: Pegfilgrastim and TC | 99.0 | 4.33 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.47
- value
- 99.1
- group Id
- OG001
- spread
- 8.45
- value
- 98.1
- title
- Docetaxel
- categories
- measurements
- group Id
- OG000
- spread
- 3.86
- value
- 99.3
- group Id
- OG001
- spread
- 4.33
- value
- 99.0
- title
- Cyclophosphamide
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 208
- units
- Participants
- description
- RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
- id
- OG000
- title
- Arm 1: SPI-2012 and TC
- description
- Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
- id
- OG001
- title
- Arm 2: Pegfilgrastim and TC
- param Type
- MEAN
- population Description
- Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population.
- reporting Status
- POSTED
- time Frame
- Cycles 1 to 4 (each cycle was 21 days)
- title
- Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4
- type
- SECONDARY
- unit Of Measure
- percentage of planned dose
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice