Stage IB-IIIA Non-small Cell Lung Carcinoma
Conditions
Keywords
Stage IB-IIA-IIIA Non-Small Cell Lung Cancer; EGFRm+; Ex19Del; L858R; AZD9291; Phase III, adjuvant chemotherapy; complete tumour resection; EGFR-TKI
Brief summary
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy
Detailed description
This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of AZD9291 versus placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. Adjuvant chemotherapy should have consisted of a platinum based doublet given for a maximum of 4 cycles.
Interventions
DRUGAZD9291 80 mg/40 mg
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
DRUGPlacebo AZD9291 80 mg/40 mg
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
DRUGOpen-label AZD9291 80 mg/40 mg
Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged at least 18 years. 2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology 3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. 4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria. 5. Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. 6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. 7. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization. 8. World Health Organization Performance Status of 0 to 1. 9. Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.
Exclusion criteria
1. Treatment with any of the following: * Pre-operative or post-operative or planned radiation therapy for the current lung cancer * Pre-operative (neo-adjuvant) platinum based or other chemotherapy * Any prior anticancer therapy * Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time * Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug * Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4 * Treatment with an investigational drug within five half-lives of the compound or any of its related material. 2. Patients who have had only segmentectomies or wedge resections 3. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years following the end of treatment. 4. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy. 5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291. 7. Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value. * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. 8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 9. Inadequate bone marrow reserve or organ function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). | Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months) | Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented. | Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS. |
| Overall Survival (OS) | Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months) | Defined as the time from the date of randomization until date of death due to any cause. |
| Overall Survival Rate at 2, 3 and 5 Years | Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented. | Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS. |
| Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years. | Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health. |
| Plasma Concentrations of AZD9291 | Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months) | The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291 |
| Plasma Concentrations of AZ5104 Metabolites | From date of dosing to week 96 (approximately 24 months) | The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites |
| Plasma Concentrations of AZ7550 Metabolites | From date of dosing to week 96 (approximately 24 months) | The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States, Vietnam
Participant flow
Recruitment details
A total of 682 Patients were randomized to treatment at 245 Centers in 25 Countries.
Pre-assignment details
During the 28 day screening period, participants were enrolled based on the presence of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations in their tumor. At the time of enrolment, all participant were required to have central confirmation of EGFR mutation status per eligibility criteria (Exon 19 deletion or L858R mutation).
Participants by arm
| Arm | Count |
|---|---|
| AZD9291 Taken once daily | 339 |
| Placebo Taken once daily | 343 |
| Total | 682 |
Baseline characteristics
| Characteristic | Placebo | AZD9291 | Total |
|---|---|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 10.5 | 62.5 Years STANDARD_DEVIATION 10.3 | 62.1 Years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized ASIAN | 218 Participants | 216 Participants | 434 Participants |
| Race/Ethnicity, Customized ASIAN (OTHER THAN CHINESE AND JAPANESE) | 65 Participants | 77 Participants | 142 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized CHINESE | 100 Participants | 95 Participants | 195 Participants |
| Race/Ethnicity, Customized HISPANIC OR LATINO | 9 Participants | 12 Participants | 21 Participants |
| Race/Ethnicity, Customized JAPANESE | 53 Participants | 47 Participants | 100 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized OTHER | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized UNKNOWN OR NOT REPORTED | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized WHITE | 122 Participants | 122 Participants | 244 Participants |
| Region of Enrollment Australia | 9 Participants | 7 Participants | 16 Participants |
| Region of Enrollment Belgium | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Brazil | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment Canada | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment China | 82 Participants | 77 Participants | 159 Participants |
| Region of Enrollment France | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment Germany | 5 Participants | 7 Participants | 12 Participants |
| Region of Enrollment Hong Kong, S.A.R., China | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment Hungary | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Israel | 3 Participants | 9 Participants | 12 Participants |
| Region of Enrollment Italy | 17 Participants | 15 Participants | 32 Participants |
| Region of Enrollment Japan | 53 Participants | 46 Participants | 99 Participants |
| Region of Enrollment Korea, Republic Of | 18 Participants | 27 Participants | 45 Participants |
| Region of Enrollment Poland | 9 Participants | 4 Participants | 13 Participants |
| Region of Enrollment Romania | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Russia | 39 Participants | 43 Participants | 82 Participants |
| Region of Enrollment Spain | 16 Participants | 14 Participants | 30 Participants |
| Region of Enrollment Sweden | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Taiwan, China | 22 Participants | 24 Participants | 46 Participants |
| Region of Enrollment Thailand | 17 Participants | 16 Participants | 33 Participants |
| Region of Enrollment Turkey | 8 Participants | 3 Participants | 11 Participants |
| Region of Enrollment Ukraine | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 8 Participants | 13 Participants | 21 Participants |
| Region of Enrollment Viet Nam | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Female | 248 Participants | 230 Participants | 478 Participants |
| Sex: Female, Male Male | 95 Participants | 109 Participants | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 42 / 339 | 82 / 343 |
| other Total, other adverse events | 312 / 337 | 262 / 343 |
| serious Total, serious adverse events | 68 / 337 | 47 / 343 |
Outcome results
Primary
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Time frame: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Population: Full Analysis Set (FAS) stage IIA-IIIA patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD9291 80mg Tablet | Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). | 65.8 Months |
| Placebo Tablet | Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). | 21.9 Months |
p-value: <0.000195% CI: [0.18, 0.3]Log Rank
Primary
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Time frame: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Population: Full Analysis Set (FAS) stage IB-IIIA patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD9291 80mg Tablet | Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). | 65.8 Months |
| Placebo Tablet | Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS). | 28.1 Months |
p-value: <0.000195% CI: [0.21, 0.34]Log Rank
Secondary
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS.
Time frame: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Population: Full analysis set (FAS) stage IIA-IIIA patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AZD9291 80mg Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 2 years (%) | 90.0 Percentage of participants |
| AZD9291 80mg Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 3 years (%) | 83.5 Percentage of participants |
| AZD9291 80mg Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 5 years (%) | 53.0 Percentage of participants |
| Placebo Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 2 years (%) | 46.1 Percentage of participants |
| Placebo Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 3 years (%) | 33.8 Percentage of participants |
| Placebo Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 5 years (%) | 24.9 Percentage of participants |
Secondary
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS.
Time frame: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Population: Full analysis set (FAS) stage IB-IIIA patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AZD9291 80mg Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 2 years (%) | 90.1 Percentage of participants |
| AZD9291 80mg Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 3 years (%) | 84.5 Percentage of participants |
| AZD9291 80mg Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 5 years (%) | 60.9 Percentage of participants |
| Placebo Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 2 years (%) | 54.5 Percentage of participants |
| Placebo Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 3 years (%) | 44.4 Percentage of participants |
| Placebo Tablet | Disease Free Survival (DFS) Rate at 2, 3 and 5 Years | DFS rate at 5 years (%) | 33.6 Percentage of participants |
Secondary
Overall Survival (OS)
Defined as the time from the date of randomization until date of death due to any cause.
Time frame: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)
Population: Full Analysis Set (FAS) stage IIA-IIIA patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD9291 80mg Tablet | Overall Survival (OS) | NA Months |
| Placebo Tablet | Overall Survival (OS) | NA Months |
p-value: 0.000495.03% CI: [0.3307, 0.7299]Log Rank
Secondary
Overall Survival (OS)
Defined as the time from the date of randomization until date of death due to any cause.
Time frame: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)
Population: Full Analysis Set (FAS) stage IB-IIIA patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD9291 80mg Tablet | Overall Survival (OS) | NA Months |
| Placebo Tablet | Overall Survival (OS) | NA Months |
p-value: <0.000195.03% CI: [0.3439, 0.7017]Log Rank
Secondary
Overall Survival Rate at 2, 3 and 5 Years
Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.
Time frame: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Population: Full Analysis Set (FAS) stage IIA-IIIA patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AZD9291 80mg Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 2 years (%) | 99.5 Percentage of participants |
| AZD9291 80mg Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 3 years (%) | 94.1 Percentage of participants |
| AZD9291 80mg Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 5 years (%) | 85.0 Percentage of participants |
| Placebo Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 2 years (%) | 92.6 Percentage of participants |
| Placebo Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 3 years (%) | 85.9 Percentage of participants |
| Placebo Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 5 years (%) | 72.6 Percentage of participants |
Secondary
Overall Survival Rate at 2, 3 and 5 Years
Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.
Time frame: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Population: Full Analysis Set (FAS) stage IB-IIIA patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AZD9291 80mg Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 2 years (%) | 99.4 Percentage of participants |
| AZD9291 80mg Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 3 years (%) | 95.3 Percentage of participants |
| AZD9291 80mg Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 5 years (%) | 87.6 Percentage of participants |
| Placebo Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 2 years (%) | 94.3 Percentage of participants |
| Placebo Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 3 years (%) | 88.8 Percentage of participants |
| Placebo Tablet | Overall Survival Rate at 2, 3 and 5 Years | OS rate at 5 years (%) | 77.7 Percentage of participants |
Secondary
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.
Time frame: Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Mental Health | 1.352 Unit on a scale | Standard Deviation 8.56 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Bodily Pain | 1.521 Unit on a scale | Standard Deviation 9.171 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Bodily Pain | 2.032 Unit on a scale | Standard Deviation 10.226 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Bodily Pain | 2.471 Unit on a scale | Standard Deviation 9.787 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Bodily Pain | 2.326 Unit on a scale | Standard Deviation 10.865 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Bodily Pain | 2.906 Unit on a scale | Standard Deviation 10.181 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Bodily Pain | 3.045 Unit on a scale | Standard Deviation 11.41 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Bodily Pain | 2.552 Unit on a scale | Standard Deviation 11.994 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - General Health Perceptions | -0.597 Unit on a scale | Standard Deviation 8.319 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - General Health Perceptions | -0.079 Unit on a scale | Standard Deviation 8.91 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - General Health Perceptions | 0.103 Unit on a scale | Standard Deviation 8.029 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - General Health Perceptions | 0.275 Unit on a scale | Standard Deviation 7.958 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - General Health Perceptions | -0.119 Unit on a scale | Standard Deviation 8.195 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - General Health Perceptions | -0.368 Unit on a scale | Standard Deviation 8.461 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - General Health Perceptions | 0.209 Unit on a scale | Standard Deviation 8.671 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - General Health Perceptions | -0.128 Unit on a scale | Standard Deviation 8.987 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Mental Health | 0.928 Unit on a scale | Standard Deviation 8.538 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Mental Health | 1.249 Unit on a scale | Standard Deviation 8.78 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Mental Health | 2.456 Unit on a scale | Standard Deviation 8.92 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Mental Health | 1.540 Unit on a scale | Standard Deviation 9.029 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Bodily Pain | 1.026 Unit on a scale | Standard Deviation 9.448 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Mental Health | 0.723 Unit on a scale | Standard Deviation 9.738 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Mental Health | 0.517 Unit on a scale | Standard Deviation 9.609 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Mental Health | 0.386 Unit on a scale | Standard Deviation 10.215 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Physical functioning | -0.314 Unit on a scale | Standard Deviation 6.762 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Physical functioning | 0.494 Unit on a scale | Standard Deviation 6.783 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Physical functioning | 0.940 Unit on a scale | Standard Deviation 7.595 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Physical functioning | 1.079 Unit on a scale | Standard Deviation 6.725 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Physical functioning | 0.637 Unit on a scale | Standard Deviation 8.22 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Physical functioning | 1.449 Unit on a scale | Standard Deviation 7.207 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Physical functioning | 1.869 Unit on a scale | Standard Deviation 6.767 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Physical functioning | 0.997 Unit on a scale | Standard Deviation 7.537 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Role Limitations - Emotional | 0.381 Unit on a scale | Standard Deviation 10.413 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Role Limitations - Emotional | 0.858 Unit on a scale | Standard Deviation 11.317 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Role Limitations - Emotional | 2.179 Unit on a scale | Standard Deviation 11.131 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Role Limitations - Emotional | 1.410 Unit on a scale | Standard Deviation 11.861 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Role Limitations - Emotional | 1.657 Unit on a scale | Standard Deviation 12.405 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Role Limitations - Emotional | 1.765 Unit on a scale | Standard Deviation 11.966 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Role Limitations - Emotional | 1.654 Unit on a scale | Standard Deviation 12.081 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Role Limitations - Emotional | 0.519 Unit on a scale | Standard Deviation 12.351 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Role Limitations - Physical | 1.056 Unit on a scale | Standard Deviation 9.263 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Role Limitations - Physical | 1.727 Unit on a scale | Standard Deviation 10.265 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Role Limitations - Physical | 3.437 Unit on a scale | Standard Deviation 10.592 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Role Limitations - Physical | 3.581 Unit on a scale | Standard Deviation 11.037 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Role Limitations - Physical | 3.240 Unit on a scale | Standard Deviation 10.807 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Role Limitations - Physical | 4.717 Unit on a scale | Standard Deviation 11.238 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Role Limitations - Physical | 3.525 Unit on a scale | Standard Deviation 10.86 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Role Limitations - Physical | 3.151 Unit on a scale | Standard Deviation 11.378 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Social Function | 1.391 Unit on a scale | Standard Deviation 9.615 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Social Function | 2.634 Unit on a scale | Standard Deviation 9.526 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Social Function | 3.731 Unit on a scale | Standard Deviation 9.919 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Social Function | 3.025 Unit on a scale | Standard Deviation 10.094 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Social Function | 3.651 Unit on a scale | Standard Deviation 10.011 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Social Function | 3.297 Unit on a scale | Standard Deviation 10.723 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Social Function | 2.582 Unit on a scale | Standard Deviation 10.638 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Social Function | 2.423 Unit on a scale | Standard Deviation 10.658 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Vitality | 0.570 Unit on a scale | Standard Deviation 7.987 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Vitality | 0.630 Unit on a scale | Standard Deviation 8.996 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Vitality | 2.231 Unit on a scale | Standard Deviation 9.209 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Vitality | 1.082 Unit on a scale | Standard Deviation 9.387 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Vitality | 1.147 Unit on a scale | Standard Deviation 9.052 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Vitality | 1.139 Unit on a scale | Standard Deviation 9.458 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Vitality | 0.386 Unit on a scale | Standard Deviation 9.724 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Vitality | 0.825 Unit on a scale | Standard Deviation 9.342 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Mental Component Summary | 0.986 Unit on a scale | Standard Deviation 8.068 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Mental Component Summary | 1.333 Unit on a scale | Standard Deviation 8.919 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Mental Component Summary | 2.788 Unit on a scale | Standard Deviation 9.301 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Mental Component Summary | 1.434 Unit on a scale | Standard Deviation 9.635 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Mental Component Summary | 1.823 Unit on a scale | Standard Deviation 9.439 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Mental Component Summary | 1.027 Unit on a scale | Standard Deviation 10.286 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Mental Component Summary | 0.580 Unit on a scale | Standard Deviation 9.994 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Mental Component Summary | 0.322 Unit on a scale | Standard Deviation 10.077 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Physical Component Summary | 0.161 Unit on a scale | Standard Deviation 6.341 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Physical Component Summary | 1.356 Unit on a scale | Standard Deviation 6.8 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Physical Component Summary | 0.878 Unit on a scale | Standard Deviation 7.009 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Physical Component Summary | 1.989 Unit on a scale | Standard Deviation 6.941 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Physical Component Summary | 1.497 Unit on a scale | Standard Deviation 7.591 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Physical Component Summary | 2.611 Unit on a scale | Standard Deviation 7.291 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Physical Component Summary | 2.635 Unit on a scale | Standard Deviation 7.374 |
| AZD9291 80mg Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Physical Component Summary | 2.133 Unit on a scale | Standard Deviation 7.909 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Physical Component Summary | 3.175 Unit on a scale | Standard Deviation 8.21 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Bodily Pain | 1.442 Unit on a scale | Standard Deviation 8.854 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Role Limitations - Physical | 2.915 Unit on a scale | Standard Deviation 8.977 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Bodily Pain | 1.462 Unit on a scale | Standard Deviation 9.279 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Vitality | 3.474 Unit on a scale | Standard Deviation 9.071 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Bodily Pain | 2.438 Unit on a scale | Standard Deviation 10.077 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Role Limitations - Physical | 4.063 Unit on a scale | Standard Deviation 9.295 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Bodily Pain | 2.335 Unit on a scale | Standard Deviation 9.566 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Mental Component Summary | 1.870 Unit on a scale | Standard Deviation 9.857 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Bodily Pain | 2.921 Unit on a scale | Standard Deviation 10.153 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Role Limitations - Physical | 5.332 Unit on a scale | Standard Deviation 9.663 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Bodily Pain | 2.778 Unit on a scale | Standard Deviation 11.295 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Vitality | 3.224 Unit on a scale | Standard Deviation 9.122 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Bodily Pain | 3.324 Unit on a scale | Standard Deviation 10.258 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Role Limitations - Physical | 5.424 Unit on a scale | Standard Deviation 9.67 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Bodily Pain | 3.116 Unit on a scale | Standard Deviation 10.692 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Physical Component Summary | 3.360 Unit on a scale | Standard Deviation 6.985 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - General Health Perceptions | 0.343 Unit on a scale | Standard Deviation 7.497 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Role Limitations - Physical | 5.321 Unit on a scale | Standard Deviation 9.997 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - General Health Perceptions | 0.763 Unit on a scale | Standard Deviation 8.122 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Vitality | 2.070 Unit on a scale | Standard Deviation 9.285 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - General Health Perceptions | 1.042 Unit on a scale | Standard Deviation 8.416 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Role Limitations - Physical | 5.348 Unit on a scale | Standard Deviation 11.395 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - General Health Perceptions | 2.339 Unit on a scale | Standard Deviation 8.197 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Mental Component Summary | 2.269 Unit on a scale | Standard Deviation 10.647 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - General Health Perceptions | 1.818 Unit on a scale | Standard Deviation 7.903 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Role Limitations - Physical | 5.444 Unit on a scale | Standard Deviation 10.547 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - General Health Perceptions | 0.964 Unit on a scale | Standard Deviation 8.518 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Vitality | 2.970 Unit on a scale | Standard Deviation 8.831 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - General Health Perceptions | 1.342 Unit on a scale | Standard Deviation 8.789 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Role Limitations - Physical | 5.572 Unit on a scale | Standard Deviation 10.954 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - General Health Perceptions | 2.166 Unit on a scale | Standard Deviation 8.67 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Physical Component Summary | 3.644 Unit on a scale | Standard Deviation 8.731 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Mental Health | 1.892 Unit on a scale | Standard Deviation 8.497 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Social Function | 3.164 Unit on a scale | Standard Deviation 9.171 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Mental Health | 1.275 Unit on a scale | Standard Deviation 9.66 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Mental Component Summary | 2.603 Unit on a scale | Standard Deviation 8.965 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Mental Health | 2.234 Unit on a scale | Standard Deviation 8.676 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Social Function | 3.433 Unit on a scale | Standard Deviation 10.348 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Mental Health | 2.011 Unit on a scale | Standard Deviation 8.954 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Physical Component Summary | 1.144 Unit on a scale | Standard Deviation 6.078 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Mental Health | 2.101 Unit on a scale | Standard Deviation 8.986 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Social Function | 4.170 Unit on a scale | Standard Deviation 10.156 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Mental Health | 2.307 Unit on a scale | Standard Deviation 10.139 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Mental Component Summary | 1.936 Unit on a scale | Standard Deviation 10.152 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Mental Health | 1.428 Unit on a scale | Standard Deviation 8.914 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Social Function | 4.802 Unit on a scale | Standard Deviation 10.351 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Mental Health | 2.000 Unit on a scale | Standard Deviation 9.651 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Physical Component Summary | 3.343 Unit on a scale | Standard Deviation 6.792 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Physical functioning | 0.898 Unit on a scale | Standard Deviation 6.646 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Social Function | 4.405 Unit on a scale | Standard Deviation 10.79 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Physical functioning | 0.923 Unit on a scale | Standard Deviation 7.014 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Mental Component Summary | 2.757 Unit on a scale | Standard Deviation 9.141 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Physical functioning | 1.914 Unit on a scale | Standard Deviation 7.899 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Social Function | 4.386 Unit on a scale | Standard Deviation 11.355 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Physical functioning | 2.042 Unit on a scale | Standard Deviation 7.283 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Physical Component Summary | 3.353 Unit on a scale | Standard Deviation 8.042 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Physical functioning | 2.016 Unit on a scale | Standard Deviation 7.048 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Social Function | 3.912 Unit on a scale | Standard Deviation 10.929 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Physical functioning | 2.540 Unit on a scale | Standard Deviation 7.424 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Mental Component Summary | 2.577 Unit on a scale | Standard Deviation 9.116 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Physical functioning | 1.939 Unit on a scale | Standard Deviation 8.238 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Social Function | 4.351 Unit on a scale | Standard Deviation 12.144 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Physical functioning | 2.187 Unit on a scale | Standard Deviation 8.293 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Physical Component Summary | 1.938 Unit on a scale | Standard Deviation 6.643 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Role Limitations - Emotional | 2.333 Unit on a scale | Standard Deviation 11.168 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 12 - Vitality | 2.344 Unit on a scale | Standard Deviation 8.207 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Role Limitations - Emotional | 1.678 Unit on a scale | Standard Deviation 11.571 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Mental Component Summary | 2.415 Unit on a scale | Standard Deviation 10.023 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Role Limitations - Emotional | 2.628 Unit on a scale | Standard Deviation 10.952 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 24 - Vitality | 2.463 Unit on a scale | Standard Deviation 9.461 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Role Limitations - Emotional | 1.860 Unit on a scale | Standard Deviation 11.424 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Physical Component Summary | 2.797 Unit on a scale | Standard Deviation 7.497 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 96 - Role Limitations - Emotional | 1.899 Unit on a scale | Standard Deviation 12.379 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 48 - Vitality | 3.029 Unit on a scale | Standard Deviation 8.972 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Role Limitations - Emotional | 2.360 Unit on a scale | Standard Deviation 12.663 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 120 - Mental Component Summary | 2.554 Unit on a scale | Standard Deviation 10.548 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 144 - Role Limitations - Emotional | 2.532 Unit on a scale | Standard Deviation 13.113 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 72 - Vitality | 3.815 Unit on a scale | Standard Deviation 8.869 |
| Placebo Tablet | Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey. | Week 156 - Role Limitations - Emotional | 2.201 Unit on a scale | Standard Deviation 13.022 |
Secondary
Plasma Concentrations of AZ5104 Metabolites
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites
Time frame: From date of dosing to week 96 (approximately 24 months)
Population: Pharmacokinetic analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 4 - Pre-dose | 44.4619 nM | Geometric Coefficient of Variation 66.2108 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 4 - 0.5-1.5 hours | 45.2280 nM | Geometric Coefficient of Variation 67.05 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 4 - 2-4 hours | 49.6081 nM | Geometric Coefficient of Variation 65.5757 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 24 - Pre-dose | 38.7314 nM | Geometric Coefficient of Variation 111.0996 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 24 - 0.5-1.5 hours | 39.1687 nM | Geometric Coefficient of Variation 86.1118 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 24 - 2-4 hours | 41.3251 nM | Geometric Coefficient of Variation 99.2633 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 48 - Pre-dose | 41.1778 nM | Geometric Coefficient of Variation 53.8923 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 48 - 0.5-1.5 hours | 40.9276 nM | Geometric Coefficient of Variation 53.9916 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 48 - 2-4 hours | 42.9143 nM | Geometric Coefficient of Variation 68.8102 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 96 - Pre-dose | 38.0205 nM | Geometric Coefficient of Variation 81.4442 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 96 - 0.5-1.5 hours | 36.9723 nM | Geometric Coefficient of Variation 101.2317 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ5104 Metabolites | Week 96 - 2-4 hours | 39.8057 nM | Geometric Coefficient of Variation 78.03 |
Secondary
Plasma Concentrations of AZ7550 Metabolites
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites
Time frame: From date of dosing to week 96 (approximately 24 months)
Population: Pharmacokinetic analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 4 - Pre-dose | 44.3492 nM | Geometric Coefficient of Variation 56.5153 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 4 - 0.5-1.5 hours | 44.7386 nM | Geometric Coefficient of Variation 55.041 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 4 - 2-4 hours | 48.0864 nM | Geometric Coefficient of Variation 61.87 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 24 - Pre-dose | 40.7113 nM | Geometric Coefficient of Variation 75.3663 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 24 - 0.5-1.5 hours | 40.9375 nM | Geometric Coefficient of Variation 65.8656 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 24 - 2-4 hours | 44.1476 nM | Geometric Coefficient of Variation 60.2684 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 48 - Pre-dose | 41.3862 nM | Geometric Coefficient of Variation 52.2259 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 48 - 0.5-1.5 hours | 41.0467 nM | Geometric Coefficient of Variation 52.9773 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 48 - 2-4 hours | 40.4486 nM | Geometric Coefficient of Variation 99.6574 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 96 - Pre-dose | 28.1890 nM | Geometric Coefficient of Variation 180.0937 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 96 - 0.5-1.5 hours | 30.2419 nM | Geometric Coefficient of Variation 155.4156 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZ7550 Metabolites | Week 96 - 2-4 hours | 33.9653 nM | Geometric Coefficient of Variation 79.2841 |
Secondary
Plasma Concentrations of AZD9291
The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291
Time frame: Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
Population: Pharmacokinetic analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 4 - Pre-dose | 380.2563 nM | Geometric Coefficient of Variation 60.4465 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 4 - 0.5-1.5 hours | 383.9142 nM | Geometric Coefficient of Variation 74.3191 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 4 - 2-4 hours | 463.0098 nM | Geometric Coefficient of Variation 56.3562 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 24- Pre-dose | 288.8266 nM | Geometric Coefficient of Variation 181.8255 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 24 - 0.5-1.5 hours | 303.8269 nM | Geometric Coefficient of Variation 116.9411 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 24 - 2-4 hours | 358.831 nM | Geometric Coefficient of Variation 116.0567 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 48- Pre-dose | 301.7346 nM | Geometric Coefficient of Variation 125.4901 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 48 - 0.5-1.5 hours | 311.3503 nM | Geometric Coefficient of Variation 101.1574 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 48 - 2-4 hours | 375.6666 nM | Geometric Coefficient of Variation 69.9838 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 96- Pre-dose | 287.5375 nM | Geometric Coefficient of Variation 95.6634 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 96 - 0.5-1.5 hours | 273.3198 nM | Geometric Coefficient of Variation 126.003 |
| AZD9291 80mg Tablet | Plasma Concentrations of AZD9291 | Week 96 - 2-4 hours | 341.5805 nM | Geometric Coefficient of Variation 79.0578 |