TriangleNCT01139775 · OUTCOME
Phase 2: Change From Baseline to Long-term Follow up in Lung Cancer Symptom Scale (LCSS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Randomization to the end of study (approximately 12 months after the last participant entered treatment)
What was measured
Health-related quality of life and participant symptoms were assessed using the LCSS (patient scale). However, improper implementation of questionnaires at the site level reduced the sponsor's ability to accurately evaluate the impacted data. Therefore, the LCSS data should be interpreted with caution. The LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. The total LCSS score was calculated as the mean of 9 questions from the LCSS.
Analysis population: All enrolled Phase 2 participants who had the baseline LCSS assessment and at least 1 post-baseline assessment.
Groups in this outcome
Phase 2: Pemetrexed + Cisplatin + LY2603618
Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
Phase 2: Pemetrexed + Cisplatin
Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
| Group | Source count |
|---|---|
| Phase 2: Pemetrexed + Cisplatin + LY2603618 | 36 |
| Phase 2: Pemetrexed + Cisplatin | 22 |
Reported measurements
Total LCSS
| Group | Source count |
|---|---|
| Phase 2: Pemetrexed + Cisplatin + LY2603618 | 32 |
| Phase 2: Pemetrexed + Cisplatin | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Pemetrexed + Cisplatin + LY2603618 | -10.7 | 14.1 | Not reported | Not reported | Not reported |
| Phase 2: Pemetrexed + Cisplatin | -11.7 | 15.1 | Not reported | Not reported | Not reported |
ASBI
| Group | Source count |
|---|---|
| Phase 2: Pemetrexed + Cisplatin + LY2603618 | 34 |
| Phase 2: Pemetrexed + Cisplatin | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Pemetrexed + Cisplatin + LY2603618 | -11.6 | 13.9 | Not reported | Not reported | Not reported |
| Phase 2: Pemetrexed + Cisplatin | -12.6 | 15.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14.1
- value
- -10.7
- group Id
- OG001
- spread
- 15.1
- value
- -11.7
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Total LCSS
- categories
- measurements
- group Id
- OG000
- spread
- 13.9
- value
- -11.6
- group Id
- OG001
- spread
- 15.4
- value
- -12.6
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- ASBI
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- Health-related quality of life and participant symptoms were assessed using the LCSS (patient scale). However, improper implementation of questionnaires at the site level reduced the sponsor's ability to accurately evaluate the impacted data. Therefore, the LCSS data should be interpreted with caution. The LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. The total LCSS score was calculated as the mean of 9 questions from the LCSS.
- dispersion Type
- Standard Deviation
- groups
- description
- Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
- id
- OG000
- title
- Phase 2: Pemetrexed + Cisplatin + LY2603618
- description
- Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
- id
- OG001
- title
- Phase 2: Pemetrexed + Cisplatin
- param Type
- MEAN
- population Description
- All enrolled Phase 2 participants who had the baseline LCSS assessment and at least 1 post-baseline assessment.
- reporting Status
- POSTED
- time Frame
- Randomization to the end of study (approximately 12 months after the last participant entered treatment)
- title
- Phase 2: Change From Baseline to Long-term Follow up in Lung Cancer Symptom Scale (LCSS)
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice