TriangleNCT02763579 · OUTCOME
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline until deterioration per symptom subscale (up to approximately 23 months)
What was measured
TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
Analysis population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
Groups in this outcome
Placebo + Carboplatin + Etoposide
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
| Group | Source count |
|---|---|
| Placebo + Carboplatin + Etoposide | 202 |
| Atezolizumab + Carboplatin + Etoposide | 201 |
Reported measurements
Cough
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Carboplatin + Etoposide | NA | Not reported | 16.6 | NA | Insufficient number of participants with events. |
| Atezolizumab + Carboplatin + Etoposide | 20.3 | Not reported | NA | NA | Insufficient number of participants with events. |
Pain in Chest
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Carboplatin + Etoposide | NA | Not reported | 10.9 | NA | Insufficient number of participants with events. |
| Atezolizumab + Carboplatin + Etoposide | NA | Not reported | NA | NA | Insufficient number of participants with events. |
Pain in Arm or Shoulder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Carboplatin + Etoposide | NA | Not reported | 8.8 | NA | Insufficient number of participants with events. |
| Atezolizumab + Carboplatin + Etoposide | NA | Not reported | 9.2 | NA | Insufficient number of participants with events. |
Dyspnea
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Carboplatin + Etoposide | 5.6 | Not reported | 3.6 | 8.8 | Not reported |
| Atezolizumab + Carboplatin + Etoposide | NA | Not reported | 5.5 | NA | Insufficient number of participants with events. |
Source statistical analyses
- ci Lower Limit
- 0.795
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.874
- group Description
- Cough
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3604
- param Type
- Hazard Ratio (HR)
- param Value
- 1.221
- statistical Method
- Log Rank
- ci Lower Limit
- 0.722
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.553
- group Description
- Pain in Chest
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7712
- param Type
- Hazard Ratio (HR)
- param Value
- 1.058
- statistical Method
- Log Rank
- ci Lower Limit
- 0.747
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.552
- group Description
- Pain in Arm or Shoulder
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.6922
- param Type
- Hazard Ratio (HR)
- param Value
- 1.077
- statistical Method
- Log Rank
- ci Lower Limit
- 0.549
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.019
- group Description
- Dyspnea
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0650
- param Type
- Hazard Ratio (HR)
- param Value
- 0.748
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.795
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.874
- group Description
- Cough
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3604
- param Type
- Hazard Ratio (HR)
- param Value
- 1.221
- statistical Method
- Log Rank
- ci Lower Limit
- 0.722
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.553
- group Description
- Pain in Chest
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7712
- param Type
- Hazard Ratio (HR)
- param Value
- 1.058
- statistical Method
- Log Rank
- ci Lower Limit
- 0.747
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.552
- group Description
- Pain in Arm or Shoulder
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.6922
- param Type
- Hazard Ratio (HR)
- param Value
- 1.077
- statistical Method
- Log Rank
- ci Lower Limit
- 0.549
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.019
- group Description
- Dyspnea
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0650
- param Type
- Hazard Ratio (HR)
- param Value
- 0.748
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 20.3
- title
- Cough
- categories
- measurements
- comment
- Insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 10.9
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Pain in Chest
- categories
- measurements
- comment
- Insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 8.8
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 9.2
- upper Limit
- NA
- value
- NA
- title
- Pain in Arm or Shoulder
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.6
- upper Limit
- 8.8
- value
- 5.6
- comment
- Insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- NA
- value
- NA
- title
- Dyspnea
- denoms
- counts
- group Id
- OG000
- value
- 202
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- id
- OG000
- title
- Placebo + Carboplatin + Etoposide
- description
- Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- id
- OG001
- title
- Atezolizumab + Carboplatin + Etoposide
- param Type
- MEDIAN
- population Description
- The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
- reporting Status
- POSTED
- time Frame
- Baseline until deterioration per symptom subscale (up to approximately 23 months)
- title
- Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
- type
- SECONDARY
- unit Of Measure
- Month
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Preserved source evidence · Not medical advice