Trial Outcomes & Findings for Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS) (NCT NCT02679170)
NCT ID: NCT02679170
Last Updated: 2024-08-09
Results Overview
ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure.
Recruitment status
COMPLETED
Target enrollment
692 participants
Primary outcome timeframe
At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
Results posted on
2024-08-09
Participant Flow
Participants with advanced/metastatic non-small cell lung cancer (NSCLC) were recruited in this multicentre, observational post-authorisation study. Participants were included in 3 sub-studies: ALK incidence, ALK treatment and ROS1 treatment sub-study. A total of 692 participants were enrolled in the study (ALK incidence sub-study= 572, ALK treatment sub-study=70 participants excluding 21 participants who were included from ALK incidence sub-study and ROS1 sub-study: 50).
Participant milestones
| Measure |
ALK Incidence Sub-study
All participants with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) diagnosed at the hospital and who underwent Anaplastic Lymphoma Kinase (ALK) translocation molecular testing subsequently were included in the incidence sub-study.
|
ALK Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
ALK Incidence Sub-study
STARTED
|
572
|
0
|
0
|
|
ALK Incidence Sub-study
Full Analysis Set
|
559
|
0
|
0
|
|
ALK Incidence Sub-study
Safety Analysis Set
|
0
|
0
|
0
|
|
ALK Incidence Sub-study
COMPLETED
|
572
|
0
|
0
|
|
ALK Incidence Sub-study
NOT COMPLETED
|
0
|
0
|
0
|
|
ALK Treatment Sub-study
STARTED
|
0
|
91
|
0
|
|
ALK Treatment Sub-study
Full Analysis Set
|
0
|
91
|
0
|
|
ALK Treatment Sub-study
Safety Analysis Set
|
0
|
91
|
0
|
|
ALK Treatment Sub-study
COMPLETED
|
0
|
91
|
0
|
|
ALK Treatment Sub-study
NOT COMPLETED
|
0
|
0
|
0
|
|
ROS1 Treatment Sub-study
STARTED
|
0
|
0
|
50
|
|
ROS1 Treatment Sub-study
Full Analysis Set
|
0
|
0
|
50
|
|
ROS1 Treatment Sub-study
Safety Analysis Set
|
0
|
0
|
50
|
|
ROS1 Treatment Sub-study
COMPLETED
|
0
|
0
|
50
|
|
ROS1 Treatment Sub-study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ALK Incidence Sub-study
n=559 Participants
All participants with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) diagnosed at the hospital and who underwent Anaplastic Lymphoma Kinase (ALK) translocation molecular testing subsequently were included in the incidence sub-study.
|
ALK Treatment Sub-study
n=70 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
Total
n=679 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
20 to 90 years
|
559 Participants
n=559 Participants
|
70 Participants
n=70 Participants
|
50 Participants
n=50 Participants
|
679 Participants
n=679 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=559 Participants
|
45 Participants
n=70 Participants
|
28 Participants
n=50 Participants
|
268 Participants
n=679 Participants
|
|
Sex: Female, Male
Male
|
364 Participants
n=559 Participants
|
25 Participants
n=70 Participants
|
22 Participants
n=50 Participants
|
411 Participants
n=679 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Number of Participants Classified According to Smoking Status
Non-smoker
|
89 Participants
n=559 Participants
|
38 Participants
n=70 Participants
|
24 Participants
n=50 Participants
|
151 Participants
n=679 Participants
|
|
Number of Participants Classified According to Smoking Status
Former-smoker
|
256 Participants
n=559 Participants
|
17 Participants
n=70 Participants
|
17 Participants
n=50 Participants
|
290 Participants
n=679 Participants
|
|
Number of Participants Classified According to Smoking Status
Smoker
|
214 Participants
n=559 Participants
|
15 Participants
n=70 Participants
|
9 Participants
n=50 Participants
|
238 Participants
n=679 Participants
|
|
Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study
Cardiovascular disease
|
0 Participants
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
18 Participants
n=70 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
35 Participants
n=50 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
53 Participants
n=120 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study
Neoplasm diseases
|
0 Participants
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
6 Participants
n=70 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
10 Participants
n=50 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
16 Participants
n=120 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study
Gastrointestinal disorders
|
0 Participants
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
6 Participants
n=70 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
6 Participants
n=50 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
12 Participants
n=120 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study
Pulmonary diseases
|
0 Participants
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
4 Participants
n=70 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
4 Participants
n=50 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
8 Participants
n=120 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study
Surgery
|
0 Participants
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
23 Participants
n=70 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
22 Participants
n=50 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
45 Participants
n=120 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study
Other
|
0 Participants
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
19 Participants
n=70 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
22 Participants
n=50 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
41 Participants
n=120 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
PRIMARY outcome
Timeframe: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=81 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=42 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
0
|
35 Participants
|
11 Participants
|
—
|
|
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
1
|
43 Participants
|
29 Participants
|
—
|
|
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
2
|
2 Participants
|
2 Participants
|
—
|
|
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
3
|
1 Participants
|
0 Participants
|
—
|
|
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
4
|
0 Participants
|
0 Participants
|
—
|
|
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
5
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)Population: For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.
Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=559 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to the Origin of Tumor Sample
Primary tumor
|
409 Participants
|
63 Participants
|
28 Participants
|
|
Number of Participants Classified According to the Origin of Tumor Sample
Metastases
|
150 Participants
|
28 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)Population: For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.
Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=559 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to Type of Sample Collected for Tumor Analysis
Biopsy
|
466 Participants
|
75 Participants
|
40 Participants
|
|
Number of Participants Classified According to Type of Sample Collected for Tumor Analysis
Cell Block
|
27 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Classified According to Type of Sample Collected for Tumor Analysis
Cytology
|
66 Participants
|
15 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease)Population: For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.
Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified \[NOS\], other) were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=559 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to Histological Subtype of Tumor
Adenocarcinoma
|
453 Participants
|
84 Participants
|
44 Participants
|
|
Number of Participants Classified According to Histological Subtype of Tumor
Squamous
|
71 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Classified According to Histological Subtype of Tumor
Large Cell
|
19 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Classified According to Histological Subtype of Tumor
NOS
|
16 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Classified According to Histological Subtype of Tumor
Other
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease)Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (\>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread \>10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study
Stage IIIA
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study
Stage IIIB
|
8 Participants
|
7 Participants
|
—
|
|
Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study
Stage IV
|
78 Participants
|
42 Participants
|
—
|
PRIMARY outcome
Timeframe: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=5 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=16 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
PD-L1+
|
4 Participants
|
14 Participants
|
—
|
|
Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
TP53+
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
AKT
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
MET
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Lymph nodes
|
30 Participants
|
16 Participants
|
—
|
|
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Lung/Pleura
|
42 Participants
|
18 Participants
|
—
|
|
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Bone
|
34 Participants
|
14 Participants
|
—
|
|
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Brain
|
11 Participants
|
4 Participants
|
—
|
|
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Liver
|
12 Participants
|
7 Participants
|
—
|
|
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Other
|
14 Participants
|
22 Participants
|
—
|
PRIMARY outcome
Timeframe: At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease)Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=51 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=19 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
2 prior treatments
|
16 Participants
|
5 Participants
|
—
|
|
Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
1 prior treatment
|
35 Participants
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
CR
|
8 Participants
|
2 Participants
|
—
|
|
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
PR
|
40 Participants
|
20 Participants
|
—
|
|
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
SD
|
22 Participants
|
12 Participants
|
—
|
|
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
PD
|
11 Participants
|
11 Participants
|
—
|
|
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Not specified/ Not evaluable
|
9 Participants
|
2 Participants
|
—
|
|
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Unknown
|
1 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
The number of participants classified as dead or alive were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Dead
|
38 Participants
|
25 Participants
|
—
|
|
Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Alive
|
53 Participants
|
25 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)Population: Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed in ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints.
QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=42 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Emotional functioning: Stable
|
13 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Economic difficulties: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Global QoL: Stable
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Physical functioning: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Role functioning: Stable
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Role functioning: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Emotional functioning: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Emotional functioning: Stable
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Emotional functioning: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Cognitive functioning: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Cognitive functioning: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Social functioning: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Social functioning: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Fatigue: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Fatigue: Stable
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Global QoL: Improvement
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Global QoL: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Global QoL: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Physical functioning: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Physical functioning: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Physical functioning: Worsening
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Role functioning: Improvement
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Role functioning: Stable
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Role functioning: Worsening
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Emotional functioning: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Emotional functioning: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Cognitive functioning: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Insomnia: Stable
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Insomnia: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Loss of appetite: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Loss of appetite: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Loss of appetite: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Constipation: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Constipation: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Constipation: Worsening
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Diarrhea: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Diarrhea: Stable
|
14 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Diarrhea: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Economic difficulties: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Economic difficulties: Stable
|
12 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Economic difficulties: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Global QoL: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Cognitive functioning: Stable
|
13 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Cognitive functioning: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Social functioning: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Social functioning: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Social functioning: Worsening
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Fatigue: Improvement
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Fatigue: Stable
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Fatigue: Worsening
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Nausea and vomiting: Improvement
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Nausea and vomiting: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Nausea and vomiting: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Pain: Improvement
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Pain: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Pain: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dyspnoea: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dyspnoea: Stable
|
13 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dyspnoea: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Insomnia: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Insomnia: Stable
|
12 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Insomnia: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Loss of appetite: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Loss of appetite: Stable
|
14 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Loss of appetite: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Constipation: Improvement
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Constipation: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Constipation: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Diarrhea: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Diarrhea: Stable
|
14 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Diarrhea: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Economic difficulties: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Economic difficulties: Stable
|
12 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Global QoL: Improvement
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Global QoL: Stable
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Global QoL: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Physical functioning: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Physical functioning: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Physical functioning: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Role functioning: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Role functioning: Stable
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Role functioning: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Emotional functioning: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Emotional functioning: Stable
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Emotional functioning: Worsening
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Cognitive functioning: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Cognitive functioning: Stable
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Cognitive functioning: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Social functioning: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Social functioning: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Social functioning: Worsening
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Fatigue: Improvement
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Fatigue: Stable
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Fatigue: Worsening
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Nausea and vomiting: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Nausea and vomiting: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Nausea and vomiting: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Pain: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Pain: Stable
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Pain: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dyspnoea: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dyspnoea: Stable
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dyspnoea: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Insomnia: Improvement
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Global QoL: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Social functioning: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Fatigue: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Physical functioning: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Physical functioning: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Role functioning: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Nausea and vomiting: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Nausea and vomiting: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Nausea and vomiting: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Pain: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Pain: Stable
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Pain: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dyspnoea: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dyspnoea: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dyspnoea: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Insomnia: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Insomnia: Stable
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Insomnia: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Loss of appetite: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Loss of appetite: Stable
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Loss of appetite: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Constipation: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Constipation: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Constipation: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Diarrhea: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Diarrhea: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Diarrhea: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Economic difficulties: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Economic difficulties: Stable
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Economic difficulties: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Cognitive functioning: Improvement
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)Population: Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer \& treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, \& medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=42 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Pain elsewhere: Stable
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Chest pain: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dyspnoea: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dyspnoea: Stable
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dyspnoea: Worsening
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Cough: Improvement
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Cough: Stable
|
11 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Cough: Worsening
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Hemoptysis: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Hemoptysis: Stable
|
22 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Hemoptysis: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Sore mouth: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Sore mouth: Stable
|
21 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Sore mouth: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dysphagia: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dysphagia: Stable
|
18 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Dysphagia: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Peripheral neuropathy: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Peripheral neuropathy: Stable
|
14 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Peripheral neuropathy: Worsening
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Alopecia: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Alopecia: Stable
|
18 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Alopecia: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Chest pain: Improvement
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Chest pain: Stable
|
13 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Arm/shoulder pain: Improvement
|
9 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Arm/shoulder pain: Stable
|
13 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Arm/shoulder pain: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Pain elsewhere: Improvement
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Pain elsewhere: Stable
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 1, Pain elsewhere: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dyspnoea: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dyspnoea: Stable
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dyspnoea: Worsening
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Cough: Improvement
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Cough: Stable
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Cough: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Hemoptysis: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Hemoptysis: Stable
|
16 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Hemoptysis: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Sore mouth: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Sore mouth: Stable
|
14 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Sore mouth: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dysphagia: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dysphagia: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Dysphagia: Worsening
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Peripheral neuropathy: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Peripheral neuropathy: Stable
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Peripheral neuropathy: Worsening
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Alopecia: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Alopecia: Stable
|
11 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Alopecia: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Chest pain: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Chest pain: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Chest pain: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Arm/shoulder pain: Improvement
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Arm/shoulder pain: Stable
|
10 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Arm/shoulder pain: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Pain elsewhere: Improvement
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Pain elsewhere: Stable
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End cycle 3, Pain elsewhere: Worsening
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dyspnoea: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dyspnoea: Stable
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dyspnoea: Worsening
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Cough: Improvement
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Cough: Stable
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Cough: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Hemoptysis: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Hemoptysis: Stable
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Hemoptysis: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Sore mouth: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Sore mouth: Stable
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Sore mouth: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dysphagia: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dysphagia: Stable
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Dysphagia: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Peripheral neuropathy: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Peripheral neuropathy: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Peripheral neuropathy: Worsening
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Alopecia: Improvement
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Alopecia: Stable
|
5 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Alopecia: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Chest pain: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Chest pain: Stable
|
4 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Chest pain: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Arm/shoulder pain: Improvement
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Arm/shoulder pain: Stable
|
3 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Arm/shoulder pain: Worsening
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Pain elsewhere: Improvement
|
1 Participants
|
—
|
—
|
|
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
Baseline-End of treatment, Pain elsewhere: Worsening
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study)Population: Analysis population included all participants presented an evaluable test for ALK translocation. This outcome measure was planned to be analyzed for ALK incidence sub-study only.
The percentage of participants with ALK positive translocations were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=559 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study
|
31 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
|
15.8 Months
Interval 11.8 to 22.3
|
7.5 Months
Interval 4.0 to 10.1
|
—
|
PRIMARY outcome
Timeframe: From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(\<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=81 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=45 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
|
59.3 Percentage of participants
|
48.9 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=32 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=16 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study
|
13.5 Months
Interval 0.0 to 48.3
|
4.4 Months
Interval 0.0 to 25.2
|
—
|
PRIMARY outcome
Timeframe: From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
|
46.5 Months
Interval 34.6 to
Upper limit of 95% CI could not be calculated due to a smaller number of participants with event.
|
21.9 Months
Interval 9.8 to
Upper limit of 95% CI could not be calculated due to a smaller number of participants with event.
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)Population: Safety population included all participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all the study screening criteria and had received at least one dose of treatment with crizotinib.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure.
Outcome measures
| Measure |
ALK Treatment Sub-study
n=91 Participants
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 Participants
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
ROS1 Treatment Sub-study
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|---|
|
Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study
Non-SAEs
|
54 Participants
|
33 Participants
|
—
|
|
Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study
SAEs
|
25 Participants
|
9 Participants
|
—
|
Adverse Events
ALK Treatment Sub-study
Serious events: 25 serious events
Other events: 54 other events
Deaths: 38 deaths
ROS1 Treatment Sub-study
Serious events: 9 serious events
Other events: 33 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
ALK Treatment Sub-study
n=91 participants at risk
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 participants at risk
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|
|
Investigations
Transaminases increased
|
6.6%
6/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
4.0%
2/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
5.5%
5/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.5%
5/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
Pain
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
Localised oedema
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Infections and infestations
Respiratory tract infection
|
3.3%
3/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Infections and infestations
Pneumonia
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Psychiatric disorders
Completed suicide
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
General deterioration of physical condition
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
4.0%
2/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Injury, poisoning and procedural complications
Post-intervention complication
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
Other adverse events
| Measure |
ALK Treatment Sub-study
n=91 participants at risk
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
ROS1 Treatment Sub-study
n=50 participants at risk
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|---|---|---|
|
Investigations
Elevated alanine aminotransferase
|
8.8%
8/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
14.0%
7/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Elevated amylase
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Elevated aspartate aminotransferase
|
6.6%
6/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
14.0%
7/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Increased blood alkaline phosphatase
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Elevated Gamma glutamyl transferase
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Increased QT Interval electrocardiography
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Elevated Transaminases
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Investigations
Decreased weight
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Infections and infestations
Oesophagic candidiasis
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Infections and infestations
Candidiasis infection
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor progression
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Cardiac disorders
Bradycardia
|
4.4%
4/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Skin and subcutaneous tissue disorders
Rash pruritus
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.8%
8/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
6.0%
3/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Reproductive system and breast disorders
Amenorrhea
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
6/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
6.0%
3/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Nervous system disorders
Dysgeusia
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Nervous system disorders
Peripheric neurophathy
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
13/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
14.0%
7/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
3/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
4.0%
2/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Upper abdominal pain
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Enteritis
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Constipation
|
11.0%
10/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
6.0%
3/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Nauseous
|
16.5%
15/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
16.0%
8/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Odynophagia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
4/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
14.0%
7/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
Asthenia
|
14.3%
13/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
20.0%
10/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
Oedema
|
16.5%
15/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
28.0%
14/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
Pyrexia
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
General disorders
Hot flushes
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Eye disorders
Vision disorders
|
11.0%
10/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
12.0%
6/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Eye disorders
Photopsia
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Eye disorders
Blepharitis/Meibomytis
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Eye disorders
Dry eye
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Renal and urinary disorders
Kidney impairment
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Effort dyspnea
|
1.1%
1/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
0.00%
0/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
2/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
|
Vascular disorders
Hypotension
|
0.00%
0/91 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
2.0%
1/50 • From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER