TriangleNCT02101788 · OUTCOME
Patient Reported Acute Peripheral Neuropathy Symptoms
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 52 weeks
What was measured
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was 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 scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
Analysis population: Patients that provided baseline and ≥ 1 follow-up assessment
Groups in this outcome
Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
Arm B (Trametinib)
Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
| Group | Source count |
|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 98 |
| Arm B (Trametinib) | 100 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 13.2 | 3.5 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 12.8 | 3.8 | Not reported | Not reported | Not reported |
12 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 12.5 | 4.0 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 12.6 | 4.2 | Not reported | Not reported | Not reported |
24 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 12.4 | 4.0 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 12.1 | 4.2 | Not reported | Not reported | Not reported |
36 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 12.3 | 3.8 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 12.6 | 3.9 | Not reported | Not reported | Not reported |
52 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 12.8 | 3.2 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 12.4 | 4.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.5
- value
- 13.2
- group Id
- OG001
- spread
- 3.8
- value
- 12.8
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 4.0
- value
- 12.5
- group Id
- OG001
- spread
- 4.2
- value
- 12.6
- title
- 12 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 4.0
- value
- 12.4
- group Id
- OG001
- spread
- 4.2
- value
- 12.1
- title
- 24 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 3.8
- value
- 12.3
- group Id
- OG001
- spread
- 3.9
- value
- 12.6
- title
- 36 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 3.2
- value
- 12.8
- group Id
- OG001
- spread
- 4.2
- value
- 12.4
- title
- 52 Weeks
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 100
- units
- Participants
- description
- Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was 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 scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
- id
- OG000
- title
- Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
- description
- Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
- id
- OG001
- title
- Arm B (Trametinib)
- param Type
- MEAN
- population Description
- Patients that provided baseline and ≥ 1 follow-up assessment
- reporting Status
- POSTED
- time Frame
- Up to 52 weeks
- title
- Patient Reported Acute Peripheral Neuropathy Symptoms
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice