TriangleNCT02953340 · OUTCOME
Relative Dose Intensity (RDI) of TC Chemotherapy
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, 2, 3 and 4 (each cycle = 21 days)
What was measured
RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned 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 analysis (SAF) population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
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 | 117 |
| (Arm 2): Pegfilgrastim and TC | 118 |
Reported measurements
Docetaxel
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (Arm 1): SPI-2012 and TC | 96.9 | 7.70 | Not reported | Not reported | Not reported |
| (Arm 2): Pegfilgrastim and TC | 98.4 | 7.89 | Not reported | Not reported | Not reported |
Cyclophosphamide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (Arm 1): SPI-2012 and TC | 98.4 | 5.27 | Not reported | Not reported | Not reported |
| (Arm 2): Pegfilgrastim and TC | 98.8 | 6.40 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.70
- value
- 96.9
- group Id
- OG001
- spread
- 7.89
- value
- 98.4
- title
- Docetaxel
- categories
- measurements
- group Id
- OG000
- spread
- 5.27
- value
- 98.4
- group Id
- OG001
- spread
- 6.40
- value
- 98.8
- title
- Cyclophosphamide
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 118
- units
- Participants
- description
- RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned 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
- 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
- MEAN
- population Description
- Safety analysis (SAF) population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
- reporting Status
- POSTED
- time Frame
- Cycles 1, 2, 3 and 4 (each cycle = 21 days)
- title
- Relative Dose Intensity (RDI) of TC Chemotherapy
- type
- SECONDARY
- unit Of Measure
- Percentage of planned dose
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice