NCT02296125 · OUTCOME
Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire)
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-04-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Unit on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Questionnaire completed in cycle 2 and 3, prior to Week 6 scan (approximately 2 months)
What was measured
The CTSQ-16 was a 16-item questionnaire measuring 3 domains related to participant's satisfaction with cancer therapy: Expectations of therapy, Feelings about side effects, and Satisfaction with therapy. Scores ranged from 0 to 100 for each domain, with a higher score associated with the best outcome on each domain. The three domains of interest were separately analysed using an ANCOVA stratified by race (Asian versus Non-Asian) and mutation type (Ex19del versus L858R). The results of the analyses were presented in terms of mean together with standard deviation.
Analysis population: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
Groups in this outcome
Osimertinib 80 mg (Global Cohort)
Randomized participants received Osimertinib 80 mg orally once daily (QD)
SoC EGFR-TKI (Global Cohort)
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
Osimertinib 80 mg (China Cohort)
Randomized participants received Osimertinib 80 mg orally once daily (QD)
SoC EGFR-TKI (China Cohort)
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
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 |
|---|
| Osimertinib 80 mg (Global Cohort) | 279 |
|---|
| SoC EGFR-TKI (Global Cohort) | 277 |
|---|
| Osimertinib 80 mg (China Cohort) | 71 |
|---|
| SoC EGFR-TKI (China Cohort) | 65 |
|---|
Reported measurements
Expectations with Therapy, Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Osimertinib 80 mg (Global Cohort) | 227 |
|---|
| SoC EGFR-TKI (Global Cohort) | 216 |
|---|
| Osimertinib 80 mg (China Cohort) | 59 |
|---|
| SoC EGFR-TKI (China Cohort) | 60 |
|---|
Values in Unit on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Osimertinib 80 mg (Global Cohort) | 74.1 | 22.42 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (Global Cohort) | 70.3 | 21.85 | Not reported | Not reported | Not reported |
|---|
| Osimertinib 80 mg (China Cohort) | 77.1 | 20.60 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (China Cohort) | 79.2 | 18.58 | Not reported | Not reported | Not reported |
|---|
Expectations with Therapy, Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Osimertinib 80 mg (Global Cohort) | 222 |
|---|
| SoC EGFR-TKI (Global Cohort) | 210 |
|---|
| Osimertinib 80 mg (China Cohort) | 60 |
|---|
| SoC EGFR-TKI (China Cohort) | 55 |
|---|
Values in Unit on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Osimertinib 80 mg (Global Cohort) | 76.3 | 20.58 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (Global Cohort) | 74.0 | 19.46 | Not reported | Not reported | Not reported |
|---|
| Osimertinib 80 mg (China Cohort) | 82.2 | 17.88 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (China Cohort) | 82.6 | 17.95 | Not reported | Not reported | Not reported |
|---|
Feelings about Side-Effects, Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Osimertinib 80 mg (Global Cohort) | 227 |
|---|
| SoC EGFR-TKI (Global Cohort) | 216 |
|---|
| Osimertinib 80 mg (China Cohort) | 59 |
|---|
| SoC EGFR-TKI (China Cohort) | 60 |
|---|
Values in Unit on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Osimertinib 80 mg (Global Cohort) | 74.5 | 17.22 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (Global Cohort) | 69.1 | 20.96 | Not reported | Not reported | Not reported |
|---|
| Osimertinib 80 mg (China Cohort) | 73.3 | 19.89 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (China Cohort) | 72.5 | 17.46 | Not reported | Not reported | Not reported |
|---|
Feelings about Side-Effects, Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Osimertinib 80 mg (Global Cohort) | 222 |
|---|
| SoC EGFR-TKI (Global Cohort) | 210 |
|---|
| Osimertinib 80 mg (China Cohort) | 60 |
|---|
| SoC EGFR-TKI (China Cohort) | 55 |
|---|
Values in Unit on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Osimertinib 80 mg (Global Cohort) | 74.6 | 19.83 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (Global Cohort) | 69.9 | 20.73 | Not reported | Not reported | Not reported |
|---|
| Osimertinib 80 mg (China Cohort) | 69.0 | 24.46 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (China Cohort) | 69.7 | 20.99 | Not reported | Not reported | Not reported |
|---|
Satisfaction with Therapy, Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Osimertinib 80 mg (Global Cohort) | 227 |
|---|
| SoC EGFR-TKI (Global Cohort) | 216 |
|---|
| Osimertinib 80 mg (China Cohort) | 59 |
|---|
| SoC EGFR-TKI (China Cohort) | 60 |
|---|
Values in Unit on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Osimertinib 80 mg (Global Cohort) | 84.4 | 12.88 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (Global Cohort) | 82.6 | 13.60 | Not reported | Not reported | Not reported |
|---|
| Osimertinib 80 mg (China Cohort) | 87.2 | 12.14 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (China Cohort) | 86.6 | 11.07 | Not reported | Not reported | Not reported |
|---|
Satisfaction with Therapy, Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Osimertinib 80 mg (Global Cohort) | 222 |
|---|
| SoC EGFR-TKI (Global Cohort) | 210 |
|---|
| Osimertinib 80 mg (China Cohort) | 60 |
|---|
| SoC EGFR-TKI (China Cohort) | 55 |
|---|
Values in Unit on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Osimertinib 80 mg (Global Cohort) | 84.2 | 13.94 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (Global Cohort) | 84.6 | 12.38 | Not reported | Not reported | Not reported |
|---|
| Osimertinib 80 mg (China Cohort) | 87.4 | 13.29 | Not reported | Not reported | Not reported |
|---|
| SoC EGFR-TKI (China Cohort) | 87.2 | 12.06 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22.42
- value
- 74.1
- group Id
- OG001
- spread
- 21.85
- value
- 70.3
- group Id
- OG002
- spread
- 20.60
- value
- 77.1
- group Id
- OG003
- spread
- 18.58
- value
- 79.2
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 216
- group Id
- OG002
- value
- 59
- group Id
- OG003
- value
- 60
- units
- Participants
- title
- Expectations with Therapy, Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 20.58
- value
- 76.3
- group Id
- OG001
- spread
- 19.46
- value
- 74.0
- group Id
- OG002
- spread
- 17.88
- value
- 82.2
- group Id
- OG003
- spread
- 17.95
- value
- 82.6
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 210
- group Id
- OG002
- value
- 60
- group Id
- OG003
- value
- 55
- units
- Participants
- title
- Expectations with Therapy, Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 17.22
- value
- 74.5
- group Id
- OG001
- spread
- 20.96
- value
- 69.1
- group Id
- OG002
- spread
- 19.89
- value
- 73.3
- group Id
- OG003
- spread
- 17.46
- value
- 72.5
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 216
- group Id
- OG002
- value
- 59
- group Id
- OG003
- value
- 60
- units
- Participants
- title
- Feelings about Side-Effects, Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 19.83
- value
- 74.6
- group Id
- OG001
- spread
- 20.73
- value
- 69.9
- group Id
- OG002
- spread
- 24.46
- value
- 69.0
- group Id
- OG003
- spread
- 20.99
- value
- 69.7
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 210
- group Id
- OG002
- value
- 60
- group Id
- OG003
- value
- 55
- units
- Participants
- title
- Feelings about Side-Effects, Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 12.88
- value
- 84.4
- group Id
- OG001
- spread
- 13.60
- value
- 82.6
- group Id
- OG002
- spread
- 12.14
- value
- 87.2
- group Id
- OG003
- spread
- 11.07
- value
- 86.6
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 216
- group Id
- OG002
- value
- 59
- group Id
- OG003
- value
- 60
- units
- Participants
- title
- Satisfaction with Therapy, Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 13.94
- value
- 84.2
- group Id
- OG001
- spread
- 12.38
- value
- 84.6
- group Id
- OG002
- spread
- 13.29
- value
- 87.4
- group Id
- OG003
- spread
- 12.06
- value
- 87.2
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 210
- group Id
- OG002
- value
- 60
- group Id
- OG003
- value
- 55
- units
- Participants
- title
- Satisfaction with Therapy, Week 6
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 277
- group Id
- OG002
- value
- 71
- group Id
- OG003
- value
- 65
- units
- Participants
- description
- The CTSQ-16 was a 16-item questionnaire measuring 3 domains related to participant's satisfaction with cancer therapy: Expectations of therapy, Feelings about side effects, and Satisfaction with therapy. Scores ranged from 0 to 100 for each domain, with a higher score associated with the best outcome on each domain. The three domains of interest were separately analysed using an ANCOVA stratified by race (Asian versus Non-Asian) and mutation type (Ex19del versus L858R). The results of the analyses were presented in terms of mean together with standard deviation.
- dispersion Type
- Standard Deviation
- groups
- description
- Randomized participants received Osimertinib 80 mg orally once daily (QD)
- id
- OG000
- title
- Osimertinib 80 mg (Global Cohort)
- description
- Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
- id
- OG001
- title
- SoC EGFR-TKI (Global Cohort)
- description
- Randomized participants received Osimertinib 80 mg orally once daily (QD)
- id
- OG002
- title
- Osimertinib 80 mg (China Cohort)
- description
- Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
- id
- OG003
- title
- SoC EGFR-TKI (China Cohort)
- param Type
- MEAN
- population Description
- The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
- reporting Status
- POSTED
- time Frame
- Questionnaire completed in cycle 2 and 3, prior to Week 6 scan (approximately 2 months)
- title
- Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire)
- type
- SECONDARY
- unit Of Measure
- Unit on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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