NCT00982111 · OUTCOME
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin · Source last updated 2022-01-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- millimeter (mm)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Cycle 6 (Cycle =3 Weeks)
What was measured
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
Analysis population: All randomized participants who had evaluable baseline and postbaseline LCSS data.
Groups in this outcome
Necitumumab + Pemetrexed + Cisplatin
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 315 |
|---|
| Pemetrexed + Cisplatin | 318 |
|---|
Reported measurements
Loss of Appetite
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 142 |
|---|
| Pemetrexed + Cisplatin | 147 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 4.6 | 46.18 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | 0.6 | 27.52 | Not reported | Not reported | Not reported |
|---|
Fatigue
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 142 |
|---|
| Pemetrexed + Cisplatin | 148 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 4.5 | 31.24 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | 1.6 | 28.75 | Not reported | Not reported | Not reported |
|---|
Cough
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 143 |
|---|
| Pemetrexed + Cisplatin | 148 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | -9.1 | 31.08 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -10.3 | 27.88 | Not reported | Not reported | Not reported |
|---|
Dyspnea
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 141 |
|---|
| Pemetrexed + Cisplatin | 146 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | -2.8 | 26.32 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -1.5 | 23.67 | Not reported | Not reported | Not reported |
|---|
Hemoptysis
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 141 |
|---|
| Pemetrexed + Cisplatin | 147 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | -1.1 | 11.92 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -1.1 | 7.81 | Not reported | Not reported | Not reported |
|---|
Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 142 |
|---|
| Pemetrexed + Cisplatin | 147 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | -4.2 | 27.22 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -7.1 | 26.64 | Not reported | Not reported | Not reported |
|---|
Overall Symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 141 |
|---|
| Pemetrexed + Cisplatin | 146 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | -3.1 | 31.22 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -7.4 | 27.11 | Not reported | Not reported | Not reported |
|---|
Quality of Life
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 142 |
|---|
| Pemetrexed + Cisplatin | 146 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 2.5 | 26.01 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -3.3 | 24.91 | Not reported | Not reported | Not reported |
|---|
Interference
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 141 |
|---|
| Pemetrexed + Cisplatin | 145 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 3.2 | 27.15 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -4.0 | 31.39 | Not reported | Not reported | Not reported |
|---|
Average Symptom Burden Index (ASBI)
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 133 |
|---|
| Pemetrexed + Cisplatin | 138 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | -0.9 | 18.35 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -3.1 | 13.11 | Not reported | Not reported | Not reported |
|---|
LCSS Total Score
Analysis denominator · Participants
| Group | Source count |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 132 |
|---|
| Pemetrexed + Cisplatin | 132 |
|---|
Values in millimeter (mm) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Necitumumab + Pemetrexed + Cisplatin | 0.1 | 17.59 | Not reported | Not reported | Not reported |
|---|
| Pemetrexed + Cisplatin | -4.3 | 13.90 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 46.18
- value
- 4.6
- group Id
- OG001
- spread
- 27.52
- value
- 0.6
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 147
- units
- Participants
- title
- Loss of Appetite
- categories
- measurements
- group Id
- OG000
- spread
- 31.24
- value
- 4.5
- group Id
- OG001
- spread
- 28.75
- value
- 1.6
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 148
- units
- Participants
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- spread
- 31.08
- value
- -9.1
- group Id
- OG001
- spread
- 27.88
- value
- -10.3
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 148
- units
- Participants
- title
- Cough
- categories
- measurements
- group Id
- OG000
- spread
- 26.32
- value
- -2.8
- group Id
- OG001
- spread
- 23.67
- value
- -1.5
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 146
- units
- Participants
- title
- Dyspnea
- categories
- measurements
- group Id
- OG000
- spread
- 11.92
- value
- -1.1
- group Id
- OG001
- spread
- 7.81
- value
- -1.1
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 147
- units
- Participants
- title
- Hemoptysis
- categories
- measurements
- group Id
- OG000
- spread
- 27.22
- value
- -4.2
- group Id
- OG001
- spread
- 26.64
- value
- -7.1
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 147
- units
- Participants
- title
- Pain
- categories
- measurements
- group Id
- OG000
- spread
- 31.22
- value
- -3.1
- group Id
- OG001
- spread
- 27.11
- value
- -7.4
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 146
- units
- Participants
- title
- Overall Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 26.01
- value
- 2.5
- group Id
- OG001
- spread
- 24.91
- value
- -3.3
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 146
- units
- Participants
- title
- Quality of Life
- categories
- measurements
- group Id
- OG000
- spread
- 27.15
- value
- 3.2
- group Id
- OG001
- spread
- 31.39
- value
- -4.0
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 145
- units
- Participants
- title
- Interference
- categories
- measurements
- group Id
- OG000
- spread
- 18.35
- value
- -0.9
- group Id
- OG001
- spread
- 13.11
- value
- -3.1
- denoms
- counts
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- Average Symptom Burden Index (ASBI)
- categories
- measurements
- group Id
- OG000
- spread
- 17.59
- value
- 0.1
- group Id
- OG001
- spread
- 13.90
- value
- -4.3
- denoms
- counts
- group Id
- OG000
- value
- 132
- group Id
- OG001
- value
- 132
- units
- Participants
- title
- LCSS Total Score
- denoms
- counts
- group Id
- OG000
- value
- 315
- group Id
- OG001
- value
- 318
- units
- Participants
- description
- The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
- dispersion Type
- Standard Deviation
- groups
- description
- Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
- id
- OG000
- title
- Necitumumab + Pemetrexed + Cisplatin
- description
- Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
- id
- OG001
- title
- Pemetrexed + Cisplatin
- param Type
- MEAN
- population Description
- All randomized participants who had evaluable baseline and postbaseline LCSS data.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 6 (Cycle =3 Weeks)
- title
- Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
- type
- SECONDARY
- unit Of Measure
- millimeter (mm)
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