TriangleNCT00063999 · OUTCOME
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
What was measured
The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
Analysis population: Eligible and evaluable and enrolled prior to 3/26/2006
Groups in this outcome
Doxorubicin, Cisplatin, Paclitaxel
Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel, Carboplatin
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Doxorubicin, Cisplatin, Paclitaxel | 228 |
| Paclitaxel, Carboplatin | 246 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin, Cisplatin, Paclitaxel | 14.9 | 0.15 | Not reported | Not reported | Not reported |
| Paclitaxel, Carboplatin | 14.9 | 0.14 | Not reported | Not reported | Not reported |
6 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin, Cisplatin, Paclitaxel | 13.5 | 0.28 | Not reported | Not reported | Not reported |
| Paclitaxel, Carboplatin | 11.3 | 0.27 | Not reported | Not reported | Not reported |
15 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin, Cisplatin, Paclitaxel | 11.1 | 0.37 | Not reported | Not reported | Not reported |
| Paclitaxel, Carboplatin | 11.2 | 0.34 | Not reported | Not reported | Not reported |
26 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin, Cisplatin, Paclitaxel | 9.5 | 0.41 | Not reported | Not reported | Not reported |
| Paclitaxel, Carboplatin | 10.9 | 0.36 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.15
- value
- 14.9
- group Id
- OG001
- spread
- 0.14
- value
- 14.9
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.28
- value
- 13.5
- group Id
- OG001
- spread
- 0.27
- value
- 11.3
- title
- 6 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.37
- value
- 11.1
- group Id
- OG001
- spread
- 0.34
- value
- 11.2
- title
- 15 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.41
- value
- 9.5
- group Id
- OG001
- spread
- 0.36
- value
- 10.9
- title
- 26 Weeks
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
- dispersion Type
- Standard Error
- groups
- description
- Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Doxorubicin, Cisplatin, Paclitaxel
- description
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Paclitaxel, Carboplatin
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Eligible and evaluable and enrolled prior to 3/26/2006
- reporting Status
- POSTED
- time Frame
- Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
- title
- Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice