Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non small cell lung cancer, Non small cell lung carcinoma, NSCLC, INC280, capmatinib, MET mutation, MET exon14, MET exon14 skipping, MET exon14 deletion, METex14, METex14del, MET∆ex14, EGFRwt, Epidermal growth factor receptor wild type, ALK negative, docetaxel
Brief summary
The purpose of the study was to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.
Detailed description
Twenty-two patients with advanced or metastatic lung cancer, with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes, were enrolled in this study. Participants were randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio. The randomization was stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines). During treatment, visits were scheduled every 21 days. For all participants, the respective treatment (either with capmatinib or docetaxel) could be continued beyond initial disease progression as per RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there was evidence of clinical benefit, and the participant wished to continue on the study treatment. After treatment discontinuation, all participants were followed for safety evaluations during the safety follow-up period, and the participant's status was collected every 12 weeks as part of the survival follow-up. Participants randomized to docetaxel treatment were eligible to cross over to receive capmatinib treatment after BIRC-confirmed, RECIST 1.1-defined progressive disease and after meeting the eligibility criteria prior to crossover. This was the extension treatment phase.
Interventions
DRUGCapmatinib
400 mg, capmatinib tablets, administered orally twice daily
DRUGDocetaxel
Docetaxel 75 mg/m\^2 by intravenous infusion every 21 days
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after blinded independent review committee (BIRC)-confirmed, RECIST 1.1- defined disease progression.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC (according to Version 8 of the American Joint Committee on Cancer (AJCC) Staging Manual) at the time of study entry. * Histologically or cytologically confirmed diagnosis of NSCLC that was: 1. EGFR wt. Assessed as part of participant's standard of care by a validated test for EGFR mutations as per local guidelines. The EGFR wt status (for EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations. 2. AND ALK rearrangement negative. Assessed as part of participant's standard of care by a validated test. 3. AND had METΔex14 mutation as determined by Novartis-designated central laboratory or by locally performed, tissue-based test, validated according to local regulation, from a Clinical Laboratory Improvement Amendments (CLIA)-certified US laboratory or an accredited local laboratory outside of the US. The positive METΔex14 mutation result as determined per local test must have been documented in the participant's source documents and in the CRF prior to entering main screening. * Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample) with quality and quantity sufficient to allow assessment of METΔex14 mutation status (as defined in the study \[laboratory manual\]). This pertained to all participants, including those who had a METΔex14 mutation result from a local test. Tumor samples must have contained at least 10% tumor content. 6\. Participants must have progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC \[not candidates for surgery, radiation or multi modality therapy\] or IV NSCLC) and must have been docetaxel naïve and candidates for single agent chemotherapy (docetaxel). Treatment failure was defined as documented disease progression or intolerance to treatment, however, participants must have progressed on or after the last therapy before study entry. * At least one measurable lesion as defined by RECIST 1.1 * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Life expectancy of at least 3 months. Key
Exclusion criteria
* Prior treatment with any MET inhibitor or HGF-targeting therapy. * Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms. * Participants with known druggable molecular alterations (such as ROS1 and RET rearrangement, BRAF mutation, KRAS mutation, NTRK fusion, etc.) which might have been a candidate for alternative targeted therapies. * Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). * Substance abuse, active infection or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may have increased the risk associated with study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1 | From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months | Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response (ORR) Per RECIST 1.1 by BIRC | Up to approximately 21 months | Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Overall Response Rate (ORR) Per RECIST 1.1 by Investigator | Up to approximately 21 months | Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Time to Response (TTR) Per RECIST 1.1 by BIRC | From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months | Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Time to Response (TTR) Per RECIST 1.1 by Investigator | From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months | Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Duration of Response (DOR) Per RECIST 1.1 by BIRC | From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months | Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Duration of Response (DOR) Per RECIST 1.1 by Investigator | From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months | Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Disease Control Rate (DCR) Per RECIST 1.1 by BIRC | Up to approximately 21 months | Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. |
| Disease Control Rate (DCR) Per RECIST 1.1 by Investigator | Up to approximately 21 months | Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. |
| Progression-free Survival (PFS) Per Investigator Using RECIST v1.1 | From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months | Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by local review according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. |
| Plasma Capmatinib Concentration | Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days. | Plasma concentrations of capmatinib. Blood samples were collected at indicated time points for pharmacokinetic analysis. |
| Overall Intracranial Response Rate (OIRR) | Up to approximately 21 months | Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose. |
| Duration of Intracranial Response (DOIR) | From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months | Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer. |
| Time to Intracranial Response (TTIR) | From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months | Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed. |
| Intracranial Disease Control Rate (IDCR) | Up to approximately 21 months | Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose. |
| Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. | EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. CFB = change from baseline. |
| Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. | EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from not at all to very much. Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. CFB = change from baseline. |
| Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. | EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. CFB = change from baseline. |
| Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days. | EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included chest pain, cough, and dyspnea and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from not at all to very much. Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. Time to symptom deterioration for chest pain, cough and dyspnea was assessed. Deterioration was assessed by the investigator. |
| Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days. | EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time to deterioration in QoL from EORTC-QLQ-C30 was assessed. Deterioration was assessed by the investigator. |
| Overall Survival (OS) | From randomization to death due to any cause, assessed up to approximately 36 months | OS was defined as the time from the date of randomization to the date of death due to any cause. |
Countries
Belgium, Brazil, Bulgaria, France, Germany, Hungary, India, Italy, Lithuania, Malaysia, Netherlands, Portugal, Russia, South Africa, South Korea, Spain, Thailand, Vietnam
Participant flow
Pre-assignment details
All inclusion and exclusion criteria were checked at screening.
Participants by arm
| Arm | Count |
|---|---|
| Capmatinib 400 mg, capmatinib tablets, administered orally twice daily | 15 |
| Docetaxel Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle | 7 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Extension Treatment Phase | Progressive disease | 0 | 5 |
| Randomized Treatment Phase | Adverse Event | 3 | 1 |
| Randomized Treatment Phase | Death | 0 | 1 |
| Randomized Treatment Phase | Not treated (participant decision) | 0 | 1 |
| Randomized Treatment Phase | Progressive disease | 9 | 4 |
| Randomized Treatment Phase | Study terminated by sponsor | 3 | 0 |
Baseline characteristics
| Characteristic | Capmatinib | Total | Docetaxel |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 9.26 | 66.8 years STANDARD_DEVIATION 8.1 | 65.1 years STANDARD_DEVIATION 4.98 |
| Race/Ethnicity, Customized Asian | 3 participants | 3 participants | 0 participants |
| Race/Ethnicity, Customized Unknown | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized White | 11 participants | 17 participants | 6 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 15 | 0 / 6 | 0 / 5 | 7 / 13 | 5 / 6 |
| other Total, other adverse events | 14 / 15 | 5 / 6 | 4 / 5 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 3 / 15 | 2 / 6 | 1 / 5 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.
Time frame: From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1 | 6.1 months |
| Docetaxel | Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1 | 4.1 months |
Secondary
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from not at all to very much. Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. CFB = change from baseline.
Time frame: Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 7, Day 1 n=8,1 | -25.0 score on a scale | Standard Deviation 15.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 9, Day 1 n=7,2 | -23.8 score on a scale | Standard Deviation 25.2 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 11, Day 1 n=7,0 | -4.8 score on a scale | Standard Deviation 23 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 13, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 15, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 27.22 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 19, Day 1 n=5,0 | -20.0 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 21, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 38.49 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 23, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 27, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 3, Day 1 n=12,4 | -2.8 score on a scale | Standard Deviation 30.01 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 5, Day 1 n=8,3 | -8.3 score on a scale | Standard Deviation 15.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 7, Day 1 n=8,1 | -8.3 score on a scale | Standard Deviation 34.5 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 9, Day 1 n=7,2 | -9.5 score on a scale | Standard Deviation 37.09 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 11, Day 1 n=7,0 | -9.5 score on a scale | Standard Deviation 53.45 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 13, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 36.51 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 15, Day 1 n=5,0 | -26.7 score on a scale | Standard Deviation 49.44 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 17, Day 1 n=4,0 | -16.7 score on a scale | Standard Deviation 57.74 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 19, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 59.63 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 21, Day 1 n=4,0 | -25.0 score on a scale | Standard Deviation 56.93 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 23, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 29, Day 1 n=2,0 | -50.0 score on a scale | Standard Deviation 70.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 37.94 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 5, Day 1 n=8,3 | -12.5 score on a scale | Standard Deviation 17.25 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 7, Day 1 n=8,1 | -12.5 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 9, Day 1 n=7,2 | -9.5 score on a scale | Standard Deviation 16.27 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 11, Day 1 n=7,0 | 4.8 score on a scale | Standard Deviation 35.63 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 13, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 14.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts at Cycle 15, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 17, Day 1 n=4,0 | 16.7 score on a scale | Standard Deviation 43.03 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 19, Day 1 n=5,0 | 20.0 score on a scale | Standard Deviation 44.72 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 21, Day 1 n= | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 27, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 3, Day 1 n=12,4 | -19.4 score on a scale | Standard Deviation 26.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 5, Day 1 n=8,3 | -8.3 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 7, Day 1 n=8,1 | -20.8 score on a scale | Standard Deviation 24.8 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 9, Day 1 n=7,2 | -23.8 score on a scale | Standard Deviation 25.2 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 11, Day 1 n=7,0 | -9.5 score on a scale | Standard Deviation 37.09 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 13, Day 1 n=5,0 | -20.0 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 15, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 36.51 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 19, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 14.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 21, Day 1 n=4,0 | -8.3 score on a scale | Standard Deviation 41.94 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 29, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 7, Day 1 n=8,1 | 4.2 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 11, Day 1 n=7,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 13, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 15, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 19, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 21, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 3, Day 1 n=12,4 | -20.4 score on a scale | Standard Deviation 21.1 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 5, Day 1 n=8,3 | -18.1 score on a scale | Standard Deviation 17.76 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 7, Day 1 n=8,1 | -8.3 score on a scale | Standard Deviation 29.55 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 9, Day 1 n=7,2 | -14.3 score on a scale | Standard Deviation 33.16 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 11, Day 1 n=7,0 | -4.8 score on a scale | Standard Deviation 32.62 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 13, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 31.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 15, Day 1 n=5,0 | -11.1 score on a scale | Standard Deviation 27.22 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 9.07 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 19, Day 1 n=5,0 | 6.7 score on a scale | Standard Deviation 30.02 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 21, Day 1 n=4,0 | -2.8 score on a scale | Standard Deviation 36.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 23, Day 1 n=2,0 | -5.6 score on a scale | Standard Deviation 7.86 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 25, Day 1 n=2,0 | -5.6 score on a scale | Standard Deviation 7.86 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 27, Day 1 n=2,0 | -5.6 score on a scale | Standard Deviation 7.86 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 15.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 25.13 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 5, Day 1 n=8,3 | -4.2 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 7, Day 1 n=8,1 | -4.2 score on a scale | Standard Deviation 27.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 9, Day 1 n=7,2 | 9.5 score on a scale | Standard Deviation 16.27 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 11, Day 1 n=7,0 | 9.5 score on a scale | Standard Deviation 16.27 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 13, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 15, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 17, Day 1 n=4,0 | 16.7 score on a scale | Standard Deviation 33.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 19, Day 1 n=5,0 | 33.3 score on a scale | Standard Deviation 33.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 21, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 25, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 27, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 14.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 5, Day 1 n=8,3 | 8.3 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 7, Day 1 n=8,1 | 12.5 score on a scale | Standard Deviation 24.8 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 9, Day 1 n=7,2 | 4.8 score on a scale | Standard Deviation 12.6 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 11, Day 1 n=7,0 | 9.5 score on a scale | Standard Deviation 16.27 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 13, Day 1 n=5,0 | 6.7 score on a scale | Standard Deviation 14.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 15, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 17, Day 1 n=4,0 | 25.0 score on a scale | Standard Deviation 31.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 19, Day 1 n=5,0 | 20.0 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 21, Day 1 n=4,0 | 25.0 score on a scale | Standard Deviation 31.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 23, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 25, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 27, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 3, Day 1 n=12,4 | 13.9 score on a scale | Standard Deviation 26.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 5, Day 1 n=8,3 | -4.2 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 7, Day 1 n=8,1 | 20.8 score on a scale | Standard Deviation 17.25 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 9, Day 1 n=7,2 | 28.6 score on a scale | Standard Deviation 23 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 11, Day 1 n=7,0 | 14.3 score on a scale | Standard Deviation 17.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 13, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 15, Day 1 n=5,0 | 6.7 score on a scale | Standard Deviation 14.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 17, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 19, Day 1 n=5,0 | 26.7 score on a scale | Standard Deviation 43.46 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 21, Day 1 n=4,0 | 25.0 score on a scale | Standard Deviation 31.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 29, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 20.72 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 5, Day 1 n=8,3 | -16.7 score on a scale | Standard Deviation 17.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | Standard Deviation 25.2 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 19.25 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 11, Day 1 n=7,0 | 9.5 score on a scale | Standard Deviation 31.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 13, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 15, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 19, Day 1 n=5,0 | 20.0 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 21, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 3, Day 1 n=12,4 | -19.4 score on a scale | Standard Deviation 22.29 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 5, Day 1 n=8,3 | -8.3 score on a scale | Standard Deviation 29.55 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 3, Day 1 n=12,4 | 16.7 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 7, Day 1 n=8,1 | 11.1 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 5, Day 1 n=8,3 | 11.1 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 9, Day 1 n=7,2 | 16.7 score on a scale | Standard Deviation 23.57 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 9, Day 1 n=7,2 | -16.7 score on a scale | Standard Deviation 23.57 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 41.94 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 47.14 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dysphagia CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 5, Day 1 n=8,3 | -22.2 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 5, Day 1 n=8,3 | -11.1 score on a scale | Standard Deviation 50.92 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 9, Day 1 n=7,2 | 16.7 score on a scale | Standard Deviation 23.57 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 3, Day 1 n=12,4 | 8.3 score on a scale | Standard Deviation 16.67 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Hemoptysis CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Chest CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 47.14 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Sore Mouth CFB at Cycle 9, Day 1 n=7,2 | 16.7 score on a scale | Standard Deviation 23.57 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 16.67 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 9, Day 1 n=7,2 | -16.7 score on a scale | Standard Deviation 70.71 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 7, Day 1 n=8,1 | 33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 3, Day 1 n=12,4 | 41.7 score on a scale | Standard Deviation 41.94 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Arm or Shoulder CFB at Cycle 3, Day 1 n=12,4 | -33.3 score on a scale | Standard Deviation 38.49 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 3, Day 1 n=12,4 | 8.3 score on a scale | Standard Deviation 31.91 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Alopecia CFB at Cycle 5, Day 1 n=8,3 | 22.2 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 9.07 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Peripheral Neuropathy CFB at Cycle 5, Day 1 n=8,3 | 11.1 score on a scale | Standard Deviation 38.49 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea CFB at Cycle 5, Day 1 n=8,3 | 14.8 score on a scale | Standard Deviation 16.97 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in Other Parts CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. CFB = change from baseline.
Time frame: Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 25, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 29, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 70.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 3, Day 1 n=12,4 | -16.7 score on a scale | Standard Deviation 38.92 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 5, Day 1 n=8,3 | 4.2 score on a scale | Standard Deviation 41.55 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 7, Day 1 n=8,1 | -12.5 score on a scale | Standard Deviation 24.8 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 9, Day 1 n=7,2 | -19.0 score on a scale | Standard Deviation 32.53 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 11, Day 1 n=7,0 | -14.3 score on a scale | Standard Deviation 42.41 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 13, Day 1 n=5,0 | -40.0 score on a scale | Standard Deviation 36.51 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 15, Day 1 n=5,0 | -33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 17, Day 1 n=4,0 | -33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 19, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 73.03 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 21, Day 1 n=4,0 | -33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 23, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 25, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 27, Day 1 n=2,0 | -33.3 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 29, Day 1 n=2,0 | -33.3 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 3, Day 1 n=12,4 | 2.8 score on a scale | Standard Deviation 38.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 5, Day 1 n=8,3 | -12.5 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 7, Day 1 n=8,1 | -4.2 score on a scale | Standard Deviation 54.74 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 9, Day 1 n=7,2 | 14.3 score on a scale | Standard Deviation 26.23 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 11, Day 1 n=7,0 | -4.8 score on a scale | Standard Deviation 44.84 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 13, Day 1 n=5,0 | -20.0 score on a scale | Standard Deviation 44.72 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 15, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 54.77 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 17, Day 1 n=4,0 | -16.7 score on a scale | Standard Deviation 57.74 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 19, Day 1 n=5,0 | -26.7 score on a scale | Standard Deviation 43.46 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 21, Day 1 n=4,0 | -16.7 score on a scale | Standard Deviation 57.74 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 23, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 27, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 24.62 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 5, Day 1 n=8,3 | -4.2 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | Standard Deviation 17.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 9, Day 1 n=7,2 | 14.3 score on a scale | Standard Deviation 17.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 11, Day 1 n=7,0 | 4.8 score on a scale | Standard Deviation 12.6 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 13, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 15, Day 1 n=5,0 | 6.7 score on a scale | Standard Deviation 14.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 17, Day 1 n=4,0 | 16.7 score on a scale | Standard Deviation 33.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 19, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 21, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 27, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 3, Day 1 n=12,4 | -2.8 score on a scale | Standard Deviation 26.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 5, Day 1 n=8,3 | -8.3 score on a scale | Standard Deviation 29.55 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 7, Day 1 n=8,1 | -4.2 score on a scale | Standard Deviation 21.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 33.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 11, Day 1 n=7,0 | 0.0 score on a scale | Standard Deviation 19.25 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 13, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 15, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 17, Day 1 n=4,0 | -8.3 score on a scale | Standard Deviation 31.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 19, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 21, Day 1 n=4,0 | 25.0 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 27, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 3, Day 1 n=12,4 | 17.4 score on a scale | Standard Deviation 18.96 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 5, Day 1 n=8,3 | 14.6 score on a scale | Standard Deviation 22.16 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 7, Day 1 n=8,1 | 15.6 score on a scale | Standard Deviation 16.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 9, Day 1 n=7,2 | 9.5 score on a scale | Standard Deviation 16.96 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 11, Day 1 n=7,0 | 3.6 score on a scale | Standard Deviation 15.85 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 13, Day 1 n=5,0 | 25.0 score on a scale | Standard Deviation 10.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 15, Day 1 n=5,0 | 10.0 score on a scale | Standard Deviation 10.87 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 17, Day 1 n=4,0 | 18.8 score on a scale | Standard Deviation 10.49 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 19, Day 1 n=5,0 | -1.7 score on a scale | Standard Deviation 19 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 21, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 23, Day 1 n=2,0 | -8.3 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 29, Day 1 n=2,0 | -29.2 score on a scale | Standard Deviation 29.46 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 3, Day 1 n=12,4 | 11.1 score on a scale | Standard Deviation 24.01 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 5, Day 1 n=8,3 | 15.0 score on a scale | Standard Deviation 21.89 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 7, Day 1 n=8,1 | 4.2 score on a scale | Standard Deviation 26.41 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 9, Day 1 n=7,2 | 7.6 score on a scale | Standard Deviation 22.25 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 11, Day 1 n=7,0 | -1.9 score on a scale | Standard Deviation 25.74 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 13, Day 1 n=5,0 | 5.3 score on a scale | Standard Deviation 25.99 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 15, Day 1 n=5,0 | -1.3 score on a scale | Standard Deviation 15.92 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 17, Day 1 n=4,0 | -5.0 score on a scale | Standard Deviation 13.74 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 19, Day 1 n=5,0 | -2.7 score on a scale | Standard Deviation 32.52 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 21, Day 1 n=4,0 | 5.0 score on a scale | Standard Deviation 10 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 9.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 25, Day 1 n=2,0 | 13.3 score on a scale | Standard Deviation 9.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 27, Day 1 n=2,0 | 3.3 score on a scale | Standard Deviation 4.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 28.28 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 3, Day 1 n=12,4 | 20.8 score on a scale | Standard Deviation 22.61 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 5, Day 1 n=8,3 | 20.8 score on a scale | Standard Deviation 29.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 7, Day 1 n=8,1 | 18.8 score on a scale | Standard Deviation 28.78 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 9, Day 1 n=7,2 | 14.3 score on a scale | Standard Deviation 22.42 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 11, Day 1 n=7,0 | 7.1 score on a scale | Standard Deviation 26.97 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 13, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 21.73 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 15, Day 1 n=5,0 | 26.7 score on a scale | Standard Deviation 19 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 13.61 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 19, Day 1 n=5,0 | 16.7 score on a scale | Standard Deviation 50 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 21, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 23, Day 1 n=2,0 | 8.3 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 3, Day 1 n=12,4 | 15.3 score on a scale | Standard Deviation 32.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 5, Day 1 n=8,3 | 15.6 score on a scale | Standard Deviation 31.32 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 7, Day 1 n=8,1 | 12.5 score on a scale | Standard Deviation 34.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 9, Day 1 n=7,2 | 8.3 score on a scale | Standard Deviation 36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 11, Day 1 n=7,0 | 1.2 score on a scale | Standard Deviation 23.29 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 13, Day 1 n=5,0 | 18.3 score on a scale | Standard Deviation 25.28 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 15, Day 1 n=5,0 | 16.7 score on a scale | Standard Deviation 19.54 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 17, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 19, Day 1 n=5,0 | 15.0 score on a scale | Standard Deviation 21.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 21, Day 1 n=4,0 | 16.7 score on a scale | Standard Deviation 15.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 25, Day 1 n=2,0 | 8.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 27, Day 1 n=2,0 | -8.3 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 29, Day 1 n=2,0 | 8.3 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 3, Day 1 n=12,4 | 12.5 score on a scale | Standard Deviation 23.7 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 5, Day 1 n=8,3 | 6.3 score on a scale | Standard Deviation 29.46 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 7, Day 1 n=8,1 | 6.3 score on a scale | Standard Deviation 33.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 9, Day 1 n=7,2 | 7.1 score on a scale | Standard Deviation 21.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 11, Day 1 n=7,0 | 4.8 score on a scale | Standard Deviation 23 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 13, Day 1 n=5,0 | 20.0 score on a scale | Standard Deviation 18.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 15, Day 1 n=5,0 | 16.7 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 17, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 21.52 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 19, Day 1 n=5,0 | 16.7 score on a scale | Standard Deviation 28.87 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 21, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 13.61 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 23, Day 1 n=2,0 | 8.3 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 27, Day 1 n=2,0 | -8.3 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 29, Day 1 n=2,0 | 41.7 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 3, Day 1 n=12,4 | 18.1 score on a scale | Standard Deviation 37.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 5, Day 1 n=8,3 | 12.5 score on a scale | Standard Deviation 44.32 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 7, Day 1 n=8,1 | -2.1 score on a scale | Standard Deviation 37.2 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 33.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 11, Day 1 n=7,0 | -2.4 score on a scale | Standard Deviation 35.26 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 13, Day 1 n=5,0 | 23.3 score on a scale | Standard Deviation 25.28 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 15, Day 1 n=5,0 | 10.0 score on a scale | Standard Deviation 25.28 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 17, Day 1 n=4,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 19, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 13.94 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 21, Day 1 n=4,0 | -16.7 score on a scale | Standard Deviation 13.61 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 23, Day 1 n=2,0 | -8.3 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 27, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 29, Day 1 n=2,0 | -8.3 score on a scale | Standard Deviation 11.79 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 3, Day 1 n=12,4 | -11.1 score on a scale | Standard Deviation 31.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 5, Day 1 n=8,3 | -12.5 score on a scale | Standard Deviation 27.5 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 7, Day 1 n=8,1 | -12.5 score on a scale | Standard Deviation 29.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 9, Day 1 n=7,2 | -12.7 score on a scale | Standard Deviation 25.2 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 11, Day 1 n=7,0 | -7.9 score on a scale | Standard Deviation 27.75 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 13, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 27.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 15, Day 1 n=5,0 | -15.6 score on a scale | Standard Deviation 16.85 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 17, Day 1 n=4,0 | -5.6 score on a scale | Standard Deviation 14.34 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 19, Day 1 n=5,0 | -4.4 score on a scale | Standard Deviation 26.76 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 21, Day 1 n=4,0 | -11.1 score on a scale | Standard Deviation 15.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 25, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 27, Day 1 n=2,0 | 5.6 score on a scale | Standard Deviation 7.86 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 29, Day 1 n=2,0 | 11.1 score on a scale | Standard Deviation 31.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 3, Day 1 n=12,4 | -1.4 score on a scale | Standard Deviation 21.86 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 5, Day 1 n=8,3 | -6.3 score on a scale | Standard Deviation 26.63 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 7, Day 1 n=8,1 | 20.8 score on a scale | Standard Deviation 39.59 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 11, Day 1 n=7,0 | 4.8 score on a scale | Standard Deviation 28.41 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 13, Day 1 n=5,0 | -3.3 score on a scale | Standard Deviation 7.45 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 15, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 17, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 31.91 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 19, Day 1 n=5,0 | 20.0 score on a scale | Standard Deviation 49.16 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 21, Day 1 n=4,0 | 20.8 score on a scale | Standard Deviation 34.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 25, Day 1 n=2,0 | 8.3 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 27, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 29, Day 1 n=2,0 | 8.3 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 3, Day 1 n=12,4 | -4.2 score on a scale | Standard Deviation 41.51 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 5, Day 1 n=8,3 | -2.1 score on a scale | Standard Deviation 31.42 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 7, Day 1 n=8,1 | -4.2 score on a scale | Standard Deviation 42.49 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 9, Day 1 n=7,2 | -4.8 score on a scale | Standard Deviation 29.99 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 11, Day 1 n=7,0 | 4.8 score on a scale | Standard Deviation 50.66 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 13, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 54.01 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 15, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 40.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 17, Day 1 n=4,0 | 12.5 score on a scale | Standard Deviation 77.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 19, Day 1 n=5,0 | 6.7 score on a scale | Standard Deviation 63.03 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 21, Day 1 n=4,0 | 4.2 score on a scale | Standard Deviation 43.83 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 23, Day 1 n=2,0 | 25.0 score on a scale | Standard Deviation 35.36 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 25, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 70.71 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 27, Day 1 n=2,0 | 33.3 score on a scale | Standard Deviation 47.14 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 29, Day 1 n=2,0 | -16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 3, Day 1 n=12,4 | -13.9 score on a scale | Standard Deviation 33.21 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 5, Day 1 n=8,3 | -12.5 score on a scale | Standard Deviation 30.54 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 7, Day 1 n=8,1 | -4.2 score on a scale | Standard Deviation 27.82 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 9, Day 1 n=7,2 | -4.8 score on a scale | Standard Deviation 23 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 11, Day 1 n=7,0 | 14.3 score on a scale | Standard Deviation 37.8 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 13, Day 1 n=5,0 | 6.7 score on a scale | Standard Deviation 27.89 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 15, Day 1 n=5,0 | 20.0 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 17, Day 1 n=4,0 | 8.3 score on a scale | Standard Deviation 16.67 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 19, Day 1 n=5,0 | 13.3 score on a scale | Standard Deviation 29.81 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 21, Day 1 n= | 16.7 score on a scale | Standard Deviation 43.03 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 23, Day 1 n=2,0 | 16.7 score on a scale | Standard Deviation 23.57 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 3, Day 1 n=12,4 | -13.9 score on a scale | Standard Deviation 26.43 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 25.2 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 7, Day 1 n=8,1 | -8.3 score on a scale | Standard Deviation 34.5 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 9, Day 1 n=7,2 | -4.8 score on a scale | Standard Deviation 35.63 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 11, Day 1 n=7,0 | 0.0 score on a scale | Standard Deviation 38.49 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 13, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 33.33 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 15, Day 1 n=5,0 | -13.3 score on a scale | Standard Deviation 38.01 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 17, Day 1 n=4,0 | 16.7 score on a scale | Standard Deviation 43.03 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 19, Day 1 n=5,0 | -6.7 score on a scale | Standard Deviation 49.44 |
| Capmatinib | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 21, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 72.01 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 3, Day 1 n=12,4 | 4.2 score on a scale | Standard Deviation 14.43 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 9, Day 1 n=7,2 | -8.3 score on a scale | Standard Deviation 11.79 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 5, Day 1 n=8,3 | 8.3 score on a scale | Standard Deviation 14.43 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 5, Day 1 n=8,3 | -22.2 score on a scale | Standard Deviation 38.49 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 7, Day 1 n=8,1 | -8.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 33.33 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Global Health Status CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 11.79 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 9, Day 1 n=7,2 | -33.3 score on a scale | Standard Deviation 47.14 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 3, Day 1 n=12,4 | -11.1 score on a scale | Standard Deviation 9.07 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 3, Day 1 n=12,4 | -25.0 score on a scale | Standard Deviation 16.67 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 5, Day 1 n=8,3 | -14.8 score on a scale | Standard Deviation 23.13 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 7, Day 1 n=8,1 | -22.2 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 5, Day 1 n=8,3 | 5.6 score on a scale | Standard Deviation 38.49 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Fatigue CFB at Cycle 9, Day 1 n=7,2 | -11.1 score on a scale | Standard Deviation 15.71 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 9.62 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 7, Day 1 n=8,1 | -16.7 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 3, Day 1 n=12,4 | -1.7 score on a scale | Standard Deviation 6.38 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 16.67 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 5, Day 1 n=8,3 | -13.3 score on a scale | Standard Deviation 23.09 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 9, Day 1 n=7,2 | -33.3 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 7, Day 1 n=8,1 | 16.7 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Physical Functioning CFB at Cycle 9, Day 1 n=7,2 | 3.3 score on a scale | Standard Deviation 14.14 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Pain CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Cognitive Functioning CFB at Cycle 9, Day 1 n=7,2 | 8.3 score on a scale | Standard Deviation 11.79 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 3, Day 1 n=12,4 | -8.3 score on a scale | Standard Deviation 16.67 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Diarrhea CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 3, Day 1 n=12,4 | 8.3 score on a scale | Standard Deviation 31.91 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 5, Day 1 n=8,3 | -11.1 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 5, Day 1 n=8,3 | -22.2 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 3, Day 1 n=12,4 | -4.2 score on a scale | Standard Deviation 20.97 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 5, Day 1 n=8,3 | 11.1 score on a scale | Standard Deviation 9.62 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 5, Day 1 n=8,3 | -5.6 score on a scale | Standard Deviation 25.46 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Financial Difficulties CFB at Cycle 5, Day 1 n=8,3 | -11.1 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 3, Day 1 n=12,4 | -4.2 score on a scale | Standard Deviation 25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Role Functioning CFB at Cycle 9, Day 1 n=7,2 | -8.3 score on a scale | Standard Deviation 11.79 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 5, Day 1 n=8,3 | -22.2 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Nausea and Vomiting CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Social Functioning CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 47.14 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Insomnia CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 5, Day 1 n=8,3 | 11.1 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Constipation CFB at Cycle 3, Day 1 n=12,4 | -16.7 score on a scale | Standard Deviation 19.25 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 3, Day 1 n=12,4 | 2.1 score on a scale | Standard Deviation 7.98 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 7, Day 1 n=8,1 | -33.3 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 5, Day 1 n=8,3 | 11.1 score on a scale | Standard Deviation 17.35 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Appetite Loss CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 47.14 |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Emotional Functioning CFB at Cycle 7, Day 1 n=8,1 | -16.7 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Dyspnea CFB at Cycle 9, Day 1 n=7,2 | 16.7 score on a scale | Standard Deviation 23.57 |
Secondary
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. CFB = change from baseline.
Time frame: Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 11, Day 1 n=7,0 | 0.1 score on a scale | Standard Deviation 1.46 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 3, Day 1 n=12,4 | -0.6 score on a scale | Standard Deviation 0.79 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 9, Day 1 n=7,2 | 0.1 score on a scale | Standard Deviation 1.35 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 21, Day 1 n=4,0 | -0.8 score on a scale | Standard Deviation 0.96 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 13, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 1.22 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 15, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 1.22 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 17, Day 1 n=4,0 | 0.0 score on a scale | Standard Deviation 1.63 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 19, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 1.58 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 21, Day 1 n=4,0 | -0.3 score on a scale | Standard Deviation 1.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 23, Day 1 n=2,0 | 1.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 25, Day 1 n=2,0 | 1.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 27, Day 1 n=2,0 | 1.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 29, Day 1 n=2,0 | -0.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 3, Day 1 n=12,4 | -0.7 score on a scale | Standard Deviation 1.23 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 5, Day 1 n=8,3 | -0.9 score on a scale | Standard Deviation 1.55 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 7, Day 1 n=8,1 | -0.8 score on a scale | Standard Deviation 1.28 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 9, Day 1 n=7,2 | -0.7 score on a scale | Standard Deviation 0.95 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 11, Day 1 n=7,0 | -0.7 score on a scale | Standard Deviation 1.38 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 13, Day 1 n=5,0 | -0.8 score on a scale | Standard Deviation 0.84 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 15, Day 1 n=5,0 | -0.4 score on a scale | Standard Deviation 0.55 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 17, Day 1 n=4,0 | -0.3 score on a scale | Standard Deviation 0.5 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 19, Day 1 n=5,0 | -0.4 score on a scale | Standard Deviation 0.55 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 23, Day 1 n=2,0 | 0.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 25, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 29, Day 1 n=2,0 | 1.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 5, Day 1 n=8,3 | -0.3 score on a scale | Standard Deviation 1.16 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 7, Day 1 n=8,1 | -0.3 score on a scale | Standard Deviation 1.39 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 11, Day 1 n=7,0 | 0.4 score on a scale | Standard Deviation 0.98 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 13, Day 1 n=5,0 | -0.4 score on a scale | Standard Deviation 1.14 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 15, Day 1 n=5,0 | -0.2 score on a scale | Standard Deviation 1.1 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 17, Day 1 n=4,0 | 0.5 score on a scale | Standard Deviation 1.29 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 19, Day 1 n=5,0 | -0.2 score on a scale | Standard Deviation 0.84 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 21, Day 1 n=4,0 | 0.5 score on a scale | Standard Deviation 1.73 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 23, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 25, Day 1 n=2,0 | -0.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 27, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 29, Day 1 n=2,0 | 0.5 score on a scale | Standard Deviation 2.12 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 3, Day 1 n=12,4 | 11.7 score on a scale | Standard Deviation 17.99 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 5, Day 1 n=8,3 | 12.6 score on a scale | Standard Deviation 12.47 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 7, Day 1 n=8,1 | 7.6 score on a scale | Standard Deviation 15.34 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 9, Day 1 n=7,2 | 6.7 score on a scale | Standard Deviation 18.29 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 11, Day 1 n=7,0 | -1.4 score on a scale | Standard Deviation 14.36 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 13, Day 1 n=5,0 | 10.8 score on a scale | Standard Deviation 21.23 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 15, Day 1 n=5,0 | 1.6 score on a scale | Standard Deviation 10.88 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 17, Day 1 n=4,0 | -4.5 score on a scale | Standard Deviation 13.77 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 19, Day 1 n=5,0 | 2.0 score on a scale | Standard Deviation 12.27 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 21, Day 1 n=4,0 | -5.0 score on a scale | Standard Deviation 10.8 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 23, Day 1 n=2,0 | -7.5 score on a scale | Standard Deviation 17.68 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 25, Day 1 n=2,0 | -4.0 score on a scale | Standard Deviation 26.87 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 27, Day 1 n=2,0 | -17.0 score on a scale | Standard Deviation 16.97 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 29, Day 1 n=2,0 | -16.5 score on a scale | Standard Deviation 9.19 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 3, Day 1 n=12,4 | -0.3 score on a scale | Standard Deviation 0.89 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 5, Day 1 n=8,3 | 0.1 score on a scale | Standard Deviation 0.99 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 7, Day 1 n=8,1 | 0.4 score on a scale | Standard Deviation 1.06 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0.82 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 11, Day 1 n=7,0 | 0.1 score on a scale | Standard Deviation 1.57 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 13, Day 1 n=5,0 | 0.6 score on a scale | Standard Deviation 1.52 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 15, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 1.58 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 17, Day 1 n=4,0 | 0.8 score on a scale | Standard Deviation 2.22 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 19, Day 1 n=5,0 | -0.2 score on a scale | Standard Deviation 1.48 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 21, Day 1 n=4,0 | 0.3 score on a scale | Standard Deviation 1.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 23, Day 1 n=2,0 | 2.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 25, Day 1 n=2,0 | 1.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 27, Day 1 n=2,0 | 1.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 29, Day 1 n=2,0 | 0.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 3, Day 1 n=12,4 | -0.3 score on a scale | Standard Deviation 0.75 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 5, Day 1 n=8,3 | -0.4 score on a scale | Standard Deviation 0.92 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 7, Day 1 n=8,1 | -0.1 score on a scale | Standard Deviation 0.83 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 9, Day 1 n=7,2 | -0.4 score on a scale | Standard Deviation 0.98 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 11, Day 1 n=7,0 | -0.1 score on a scale | Standard Deviation 1.07 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 13, Day 1 n=5,0 | -0.2 score on a scale | Standard Deviation 0.84 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 15, Day 1 n=5,0 | 0.2 score on a scale | Standard Deviation 0.45 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 17, Day 1 n=4,0 | 0.3 score on a scale | Standard Deviation 0.96 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 19, Day 1 n=5,0 | 0.0 score on a scale | Standard Deviation 1 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 21, Day 1 n=4,0 | -0.3 score on a scale | Standard Deviation 0.96 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 23, Day 1 n=2,0 | 0.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 25, Day 1 n=2,0 | 0.5 score on a scale | Standard Deviation 0.71 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 27, Day 1 n=2,0 | 1.0 score on a scale | Standard Deviation 1.41 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 29, Day 1 n=2,0 | 0.0 score on a scale | Standard Deviation 0 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 3, Day 1 n=12,4 | -0.2 score on a scale | Standard Deviation 0.72 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 5, Day 1 n=8,3 | 0.5 score on a scale | Standard Deviation 0.76 |
| Capmatinib | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | Standard Deviation 1.2 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0.82 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 9, Day 1 n=7,2 | 5.0 score on a scale | Standard Deviation 8.49 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 5, Day 1 n=8,3 | -0.7 score on a scale | Standard Deviation 1.53 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 3, Day 1 n=12,4 | -0.3 score on a scale | Standard Deviation 0.96 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 7, Day 1 n=8,1 | -1.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 9, Day 1 n=7,2 | 1.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 1.41 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 5, Day 1 n=8,3 | 0.7 score on a scale | Standard Deviation 1.53 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 9, Day 1 n=7,2 | 1.5 score on a scale | Standard Deviation 0.71 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility CFB at Cycle 9, Day 1 n=7,2 | 1.0 score on a scale | Standard Deviation 1.41 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 3, Day 1 n=12,4 | 1.3 score on a scale | Standard Deviation 0.5 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 9, Day 1 n=7,2 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 3, Day 1 n=12,4 | 0.3 score on a scale | Standard Deviation 0.96 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self-Care CFB at Cycle 3, Day 1 n=12,4 | 0.0 score on a scale | Standard Deviation 0 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 3, Day 1 n=12,4 | 10.3 score on a scale | Standard Deviation 11.32 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 5, Day 1 n=8,3 | 0.0 score on a scale | Standard Deviation 1 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 5, Day 1 n=8,3 | 10.3 score on a scale | Standard Deviation 5.03 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities CFB at Cycle 5, Day 1 n=8,3 | 0.7 score on a scale | Standard Deviation 0.58 |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ VAS Score CFB at Cycle 7, Day 1 n=8,1 | -6.0 score on a scale | — |
| Docetaxel | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort CFB at Cycle 7, Day 1 n=8,1 | 0.0 score on a scale | — |
Secondary
Disease Control Rate (DCR) Per RECIST 1.1 by BIRC
Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time frame: Up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capmatinib | Disease Control Rate (DCR) Per RECIST 1.1 by BIRC | 73.3 percentage of participants |
| Docetaxel | Disease Control Rate (DCR) Per RECIST 1.1 by BIRC | 57.1 percentage of participants |
Secondary
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator
Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time frame: Up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capmatinib | Disease Control Rate (DCR) Per RECIST 1.1 by Investigator | 86.7 percentage of participants |
| Docetaxel | Disease Control Rate (DCR) Per RECIST 1.1 by Investigator | 42.9 percentage of participants |
Secondary
Duration of Intracranial Response (DOIR)
Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer.
Time frame: From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months
Population: The duration of intracranial response could not be analyzed as there were no participants with intracranial response. The analysis population was all participants with intracranial response.
Secondary
Duration of Response (DOR) Per RECIST 1.1 by BIRC
Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Duration of Response (DOR) Per RECIST 1.1 by BIRC | 12.6 months |
Secondary
Duration of Response (DOR) Per RECIST 1.1 by Investigator
Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Duration of Response (DOR) Per RECIST 1.1 by Investigator | 9.9 months |
| Docetaxel | Duration of Response (DOR) Per RECIST 1.1 by Investigator | 3.1 months |
Secondary
Intracranial Disease Control Rate (IDCR)
Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose.
Time frame: Up to approximately 21 months
Population: The full analysis set - brain metastases (FAS-BM) comprised all participants in the FAS who had measurable and/or non-measurable brain metastases at baseline as determined by the BIRC and at least one post-baseline assessment. The FAS-BM was used in the analyses of intracranial anti-tumor activity per RANO-BM criteria. Data are reported for responders only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capmatinib | Intracranial Disease Control Rate (IDCR) | 100 percentage of participants |
Secondary
Overall Intracranial Response Rate (OIRR)
Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose.
Time frame: Up to approximately 21 months
Population: The full analysis set - brain metastases (FAS-BM) comprised all participants in the FAS who had measurable and/or non-measurable brain metastases at baseline as determined by the BIRC and at least one post-baseline assessment. The FAS-BM was used in the analyses of intracranial anti-tumor activity per RANO-BM criteria. Data are reported for responders only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capmatinib | Overall Intracranial Response Rate (OIRR) | 0 Percentage of participants |
Secondary
Overall Response (ORR) Per RECIST 1.1 by BIRC
Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capmatinib | Overall Response (ORR) Per RECIST 1.1 by BIRC | 53.3 percentage of participants |
| Docetaxel | Overall Response (ORR) Per RECIST 1.1 by BIRC | 0 percentage of participants |
Secondary
Overall Response Rate (ORR) Per RECIST 1.1 by Investigator
Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capmatinib | Overall Response Rate (ORR) Per RECIST 1.1 by Investigator | 46.7 percentage of participants |
| Docetaxel | Overall Response Rate (ORR) Per RECIST 1.1 by Investigator | 14.3 percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From randomization to death due to any cause, assessed up to approximately 36 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Overall Survival (OS) | 12.5 months |
| Docetaxel | Overall Survival (OS) | 13.6 months |
Secondary
Plasma Capmatinib Concentration
Plasma concentrations of capmatinib. Blood samples were collected at indicated time points for pharmacokinetic analysis.
Time frame: Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days.
Population: The pharmacokinetic analysis set (PAS) included all participants who received at least one dose of capmatinib and had at least one steady state evaluable post-baseline capmatinib concentration measurement.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Capmatinib | Plasma Capmatinib Concentration | Cycle 1, Day 15, 0 hour n=12 | 496 μg/mL | Geometric Coefficient of Variation 97.3 |
| Capmatinib | Plasma Capmatinib Concentration | Cycle 1, Day 15, 1 hour n=10 | 1330 μg/mL | Geometric Coefficient of Variation 214.6 |
| Capmatinib | Plasma Capmatinib Concentration | Cycle 1, Day 15, 4 hours n=11 | 2680 μg/mL | Geometric Coefficient of Variation 131.1 |
| Capmatinib | Plasma Capmatinib Concentration | Cycle 3, Day 1, 0 hour n=10 | 243 μg/mL | Geometric Coefficient of Variation 140.6 |
Secondary
Progression-free Survival (PFS) Per Investigator Using RECIST v1.1
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by local review according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2.
Time frame: From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Progression-free Survival (PFS) Per Investigator Using RECIST v1.1 | 6.1 months |
| Docetaxel | Progression-free Survival (PFS) Per Investigator Using RECIST v1.1 | 3.6 months |
Secondary
Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time to deterioration in QoL from EORTC-QLQ-C30 was assessed. Deterioration was assessed by the investigator.
Time frame: Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | NA months |
| Docetaxel | Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | NA months |
Secondary
Time to Intracranial Response (TTIR)
Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed.
Time frame: From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months
Population: The median time to intracranial response was not evaluable in both treatment arms as there were no responders.
Secondary
Time to Response (TTR) Per RECIST 1.1 by BIRC
Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Time to Response (TTR) Per RECIST 1.1 by BIRC | 3.2 months |
Secondary
Time to Response (TTR) Per RECIST 1.1 by Investigator
Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capmatinib | Time to Response (TTR) Per RECIST 1.1 by Investigator | 1.3 months |
| Docetaxel | Time to Response (TTR) Per RECIST 1.1 by Investigator | 2.8 months |
Secondary
Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included chest pain, cough, and dyspnea and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from not at all to very much. Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. Time to symptom deterioration for chest pain, cough and dyspnea was assessed. Deterioration was assessed by the investigator.
Time frame: Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.
Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Capmatinib | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing | 13.9 months |
| Capmatinib | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea | 5.7 months |
| Capmatinib | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in chest | 11.1 months |
| Docetaxel | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Coughing | 2.9 months |
| Docetaxel | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Dyspnea | 2.9 months |
| Docetaxel | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | Pain in chest | 2.9 months |
Post Hoc
All Collected Deaths
On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.
Time frame: On-treatment deaths: Up to approximately 117 weeks. Post-treatment survival follow-up deaths: Up to an additional 36 weeks.
Population: The safety set included all participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Capmatinib | All Collected Deaths | On-treatment deaths | 2 Participants |
| Capmatinib | All Collected Deaths | Post-treatment deaths | 7 Participants |
| Capmatinib | All Collected Deaths | All deaths | 9 Participants |
| Docetaxel | All Collected Deaths | On-treatment deaths | 0 Participants |
| Docetaxel | All Collected Deaths | Post-treatment deaths | 5 Participants |
| Docetaxel | All Collected Deaths | All deaths | 5 Participants |