Metastatic Renal Cell Carcinoma
Conditions
Keywords
metastatic renal cell carcinoma
Brief summary
The purpose of this study is to know about the quality of life of patients with metastatic renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or cure such side effects that affect patients.
Detailed description
Prospective, multicentre, observational study in patients with metastatic renal cell carcinoma (mRCC) receiving a tyrosine kinase inhibitor as first-line treatment according to routine clinical practice, designed to evaluate the incidence of fatigue and hand-foot syndrome in order to determine how these affect the baseline characteristics of the patient and his/her disease (age, gender, baseline status, tumour histology, etc.) and the patient's lifestyle as such side effects develop. An exploratory analysis will be performed of measures that clinicians may adopt to improve patients' quality of life with regards to daytime naps, medication administration time, off-treatment periods, dose reductions and treatment breaks.
Interventions
None listed
Sponsors
TFS Trial Form Support
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old and diagnosed with metastatic RCC who, in the investigator's opinion, are candidates for starting first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice. * Patients who have no contraindications to the treatment. * Baseline ECOG ≤ 2. * Patients who are able to give informed consent on their own without the need for a legal representative. * Committed patients who are able to complete the quality of life questionnaires and patient diary on their own without the need for a legal representative.
Exclusion criteria
* Patients who are not candidates for first-line treatment with a tyrosine kinase inhibitor. * Patients who are receiving the treatment as second-line or subsequent therapy. * Untreated hypothyroidism. * Untreated severe anaemia. * Pregnancy or breast-feeding. * Myocardial infarction or cerebrovascular accidents (CVA) within the last 6 months. * Severe hepatic impairment. * Concomitant use of potent inhibitors or inducers that interact with hepatic cytochrome CYP3A4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Categorized According to the Napping Habits for All Participants at Baseline | Baseline | In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays. |
| Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 | Week 12 | In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays. |
| Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 | Week 24 | In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays. |
| Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 | Week 36 | In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays. |
| Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Baseline | In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes. |
| Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Week 12 | In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes. |
| Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Week 24 | In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes. |
| Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Week 36 | In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline | Baseline | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6 | Week 6 | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 | Week 12 | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18 | Week 18 | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 | Week 24 | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30 | Week 30 | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36 | Week 36 | FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants. |
| Number of Participants Classified According to Time of Taking Treatment at Week 1 | Week 1 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Classified According to Time of Taking Treatment at Week 6 | Week 6 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Classified According to Time of Taking Treatment at Week 12 | Week 12 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Classified According to Time of Taking Treatment at Week 18 | Week 18 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Classified According to Time of Taking Treatment at Week 24 | Week 24 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Classified According to Time of Taking Treatment at Week 30 | Week 30 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Classified According to Time of Taking Treatment at Week 36 | Week 36 | In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified. |
| Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | During 9 months | In this outcome measure, number of participants were classified according to the number of changes to dose that is (i.e). 0, 1 or 2 occurred per treatment cycle during 9 months of follow-up. |
| Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | During 9 months | In this outcome measure, number of participants were classified according to the number of interruptions to dose i.e. 0, 1, 2, 3 or 4 occurred in each treatment cycle during 9 months follow-up. |
| Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) | From start of treatment with TKI until first documented best response of CR, PR, SD or DP (approximately maximum up to 3.8 years) | Best response was recorded from start of treatment with TKI until best complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP) was achieved. RECIST v1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions \[TLs\]) or non-target lesions (non-TLs) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs; b) PR: \>=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters; c) DP: \>=20% increase in sum of diameter of all TLs, taking as reference the smallest sum on study (including baseline measurement), sum must also be absolute increase of \>=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion; d) SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for PD referring smallest sum diameter. Participant whose best response was not determined were classified as Undetermined. |
| Mean Duration of Treatment | From start of treatment till end of treatment (approximately maximum up to 3.8 years) | In this outcome measure, the mean duration of treatment was calculated and reported below. |
| Time to Treatment Failure (TTF) After Initiation of Tyrosine Kinase Inhibitor Therapy | From start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause or till follow-up in case of no event (approximately maximum up to 3.8 years) | TTF was defined as the time from the start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause. Participants who did not had the event were censored on the date of their final follow-up. Per RECIST 1.1, tumour progression: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion. |
| Number of Participants Categorized According to Number of Treatment Cycles Received | From start of treatment till end of treatment (approximately maximum up to 3.8 years) | In this outcome measure, number of participants were classified according to number of treatment cycles received. |
| Progression-Free Survival (PFS) | From start of treatment with a TKI to tumour progression or death for any reason or till follow-up in case of no event (approximately maximum up to 3.8 years) | PFS was defined as the time from the start of treatment with a TKI to tumour progression or death for any reason. Participants who, did not had the event were censored on the date of their final follow-up. Per RECIST v1.1, tumour progression: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion. |
| Objective Response Rate (ORR) | From start of treatment with TKI until first documented CR or PR (approximately maximum up to 3.8 years) | ORR was defined as the percentage of participants who achieved CR or PR. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs; b) PR: \>=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. |
| Duration of Response (DOR) | From day of documented CR or PR to the first day that DP was observed (approximately maximum up to 3.8 years) | In participants who achieved CR or PR, DOR was defined as the duration from the documentation date of CR or PR to the first day when DP was observed. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-target lesions; b) PR: \>=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) DP: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement), sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion. |
| Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | During 9 months | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with fatigue event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4. |
| Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | During 9 months | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with hand foot syndrome event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4. |
| Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 | Week 12 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 12 are reported. |
| Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 | Week 24 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 24 are reported. |
| Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 | Week 36 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 36 are reported. |
Countries
Spain
Participant flow
Recruitment details
Participants aged above or equal to 18 years, who were diagnosed with metastatic renal cell carcinoma (mRCC), and were to initiate tyrosine kinase inhibitor (TKI) as first-line treatment as per normal routine healthcare practice in real world were included in this prospective, observational study. Participants were to be followed up for at least 9 months after treatment initiation and till they switched to second line treatment before end of the study (maximum duration of 3.8 years).
Participants by arm
| Arm | Count |
|---|---|
| Tyrosine Kinase Inhibitor Participants diagnosed with mRCC who received TKI as first line treatment, prescribed by physician, in real world practice were observed in this study. | 111 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dropped out/Died | 58 |
Baseline characteristics
| Characteristic | Tyrosine Kinase Inhibitor | — |
|---|---|---|
| Age, Continuous | 62.9 Years STANDARD_DEVIATION 10.7 | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2 0 | 55 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2 1 | 45 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Less Than or Equal to (<=) 2 2 | 11 Participants | — |
| Heng Prognostic Criteria Favourable | 28 Participants | — |
| Heng Prognostic Criteria Intermediate | 57 Participants | — |
| Heng Prognostic Criteria Poor prognosis | 26 Participants | — |
| Histological Type Chromophobe | 3 Participants | — |
| Histological Type Clear cell | 86 Participants | — |
| Histological Type Mixed | 3 Participants | — |
| Histological Type Not performed | 8 Participants | — |
| Histological Type Papillary type 1 | 4 Participants | — |
| Histological Type Papillary type 2 | 5 Participants | — |
| Histological Type Sarcomatoid | 2 Participants | — |
| Number of Metastatic Sites 1 | 47 Participants | — |
| Number of Metastatic Sites 2 | 36 Participants | — |
| Number of Metastatic Sites 3 | 19 Participants | — |
| Number of Metastatic Sites 4 | 6 Participants | — |
| Number of Metastatic Sites 5 | 3 Participants | — |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Pazopanib 800 mg daily without rest days | 11 Participants | — |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 25 mg, Regimen 2/1 | 2 Participants | — |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 37.5 mg, Regimen 2/1 | 3 Participants | — |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 37.5 mg, Regimen 4/2 | 2 Participants | — |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 50 mg, Regimen 2/1 | 10 Participants | — |
| Number of Participants Categorized According to Tyrosine Kinase Inhibitor Dose and Treatment Regimen Sunitinib 50 mg, Regimen 4/2 | 83 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 80 Participants | — |
| Site of Metastasis Bone | 29 Participants | — |
| Site of Metastasis Brain | 3 Participants | — |
| Site of Metastasis Kidney | 9 Participants | — |
| Site of Metastasis Liver | 26 Participants | — |
| Site of Metastasis Lung | 73 Participants | — |
| Site of Metastasis Nodes | 38 Participants | — |
| Site of Metastasis Other | 32 Participants | — |
| Smoking Status Former Smoker | 11 Participants | — |
| Smoking Status No | 79 Participants | — |
| Smoking Status Occasional | 1 Participants | — |
| Smoking Status Yes | 20 Participants | — |
| Time Elapsed From the Time of Advanced Diagnosis of the Disease | 2.6 Months STANDARD_DEVIATION 4.8 | — |
| Time Elapsed From the Time of Diagnosis of the Disease | 31.5 Months STANDARD_DEVIATION 56.9 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 100 | 1 / 11 |
| other Total, other adverse events | 82 / 100 | 6 / 11 |
| serious Total, serious adverse events | 23 / 100 | 5 / 11 |
Outcome results
Primary
Duration of Response (DOR)
In participants who achieved CR or PR, DOR was defined as the duration from the documentation date of CR or PR to the first day when DP was observed. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-target lesions; b) PR: \>=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters; c) DP: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement), sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion.
Time frame: From day of documented CR or PR to the first day that DP was observed (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants with documented CR or PR.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Duration of Response (DOR) | 11.8 Months | Standard Deviation 7.3 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Baseline
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Baseline | 40.0 Units on a scale | Standard Deviation 9.6 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Week 12
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 | 36.4 Units on a scale | Standard Deviation 10.6 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Week 18
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 18 | 35.3 Units on a scale | Standard Deviation 11.5 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Week 24
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 | 36.3 Units on a scale | Standard Deviation 11.1 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Week 30
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 30 | 34.9 Units on a scale | Standard Deviation 11.3 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Week 36
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 36 | 35.5 Units on a scale | Standard Deviation 10.2 |
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6
FACIT-F was a 13-item questionnaire which assessed self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4= very much). FACIT-F score was calculated by summing the 13 items (range 0 \[not at all\] to 52 \[very much\]); higher scores represented less fatigue and better status of participants.
Time frame: Week 6
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 6 | 34.7 Units on a scale | Standard Deviation 11.4 |
Primary
Mean Duration of Treatment
In this outcome measure, the mean duration of treatment was calculated and reported below.
Time frame: From start of treatment till end of treatment (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Mean Duration of Treatment | 8.9 Months | Standard Deviation 7.7 |
Primary
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Time frame: Baseline
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Fatigue: Yes | Never Exercise | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Fatigue: Yes | Always Exercise | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Fatigue: Yes | Sometimes Exercise | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Fatigue: No | Never Exercise | 34 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Fatigue: No | Always Exercise | 14 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Baseline | Fatigue: No | Sometimes Exercise | 22 Participants |
Primary
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Time frame: Week 12
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Fatigue: Yes | Never Exercise | 14 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Fatigue: Yes | Always Exercise | 6 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Fatigue: Yes | Sometimes Exercise | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Fatigue: No | Never Exercise | 9 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Fatigue: No | Always Exercise | 12 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 12 | Fatigue: No | Sometimes Exercise | 11 Participants |
Primary
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Time frame: Week 24
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Fatigue: Yes | Never Exercise | 13 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Fatigue: Yes | Always Exercise | 5 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Fatigue: Yes | Sometimes Exercise | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Fatigue: No | Never Exercise | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Fatigue: No | Always Exercise | 5 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 24 | Fatigue: No | Sometimes Exercise | 7 Participants |
Primary
Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36
In this outcome measure, number of participants were classified according to the presence or absence of fatigue based on their habit of performing aerobic physical exercise as never, always and sometimes.
Time frame: Week 36
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Fatigue: Yes | Always Exercise | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Fatigue: Yes | Sometimes Exercise | 3 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Fatigue: No | Never Exercise | 19 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Fatigue: Yes | Never Exercise | 4 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Fatigue: No | Always Exercise | 5 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Association Between the Practice of Aerobic Physical Exercise and Fatigue at Week 36 | Fatigue: No | Sometimes Exercise | 9 Participants |
Primary
Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up
In this outcome measure, number of participants were classified according to the number of changes to dose that is (i.e). 0, 1 or 2 occurred per treatment cycle during 9 months of follow-up.
Time frame: During 9 months
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 1 | 0 | 82 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 1 | 1 | 19 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 1 | 2 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 2 | 0 | 69 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 2 | 1 | 25 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 2 | 2 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 3 | 0 | 55 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 3 | 1 | 17 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 3 | 2 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 4 | 0 | 60 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 4 | 1 | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 4 | 2 | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 5 | 0 | 46 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 5 | 1 | 9 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 5 | 2 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 6 | 0 | 49 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 6 | 1 | 4 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Changes to Dose Per Treatment Cycle During 9 Months of Follow-up | Changes to Dose Occurred in Cycle 6 | 2 | 0 Participants |
Primary
Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up
In this outcome measure, number of participants were classified according to the number of interruptions to dose i.e. 0, 1, 2, 3 or 4 occurred in each treatment cycle during 9 months follow-up.
Time frame: During 9 months
Population: Analysis population included all eligible participants who were included in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 1 | 0 | 76 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 1 | 1 | 25 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 1 | 2 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 1 | 3 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 1 | 4 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 2 | 0 | 73 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 2 | 1 | 16 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 2 | 2 | 5 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 2 | 3 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 2 | 4 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 3 | 0 | 59 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 3 | 1 | 9 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 3 | 2 | 3 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 3 | 3 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 3 | 4 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 4 | 0 | 58 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 4 | 1 | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 4 | 2 | 2 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 4 | 3 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 4 | 4 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 5 | 0 | 39 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 5 | 1 | 12 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 5 | 2 | 2 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 5 | 3 | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 5 | 4 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 6 | 0 | 41 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 6 | 1 | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 6 | 2 | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 6 | 3 | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Interruptions to Dose Occurred in Each Treatment Cycle During 9 Months of Follow-up | Interruptions in Cycle 6 | 4 | 0 Participants |
Primary
Number of Participants Categorized According to Number of Treatment Cycles Received
In this outcome measure, number of participants were classified according to number of treatment cycles received.
Time frame: From start of treatment till end of treatment (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 0 cycles | 2 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 1 cycle | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 2 cycles | 21 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 3 cycles | 8 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 4 cycles | 12 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 5 cycles | 3 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 6 cycles | 4 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 7 cycles | 9 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 8 cycles | 5 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 9 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 10 cycles | 4 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 11 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 12 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 13 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 14 cycles | 2 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 15 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 17 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 19 cycles | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to Number of Treatment Cycles Received | 25 cycles | 1 Participants |
Primary
Number of Participants Categorized According to the Napping Habits for All Participants at Baseline
In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.
Time frame: Baseline
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Baseline | Never | 22 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Baseline | Always | 33 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Baseline | Sometimes | 31 Participants |
Primary
Number of Participants Categorized According to the Napping Habits for All Participants at Week 12
In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.
Time frame: Week 12
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 | Never | 18 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 | Always | 24 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 12 | Sometimes | 21 Participants |
Primary
Number of Participants Categorized According to the Napping Habits for All Participants at Week 24
In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.
Time frame: Week 24
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 | Never | 18 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 | Always | 15 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 24 | Sometimes | 12 Participants |
Primary
Number of Participants Categorized According to the Napping Habits for All Participants at Week 36
In this outcome measure, number of participants were classified according to their habit of taking daytime rest (naps) as never, always and sometimes. Never is defined as someone who does not take any daytime nap, always is defined as someone who takes daytime naps daily and sometimes is defined as someone who takes daytime naps on weekends or on holidays.
Time frame: Week 36
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 | Never | 16 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 | Always | 16 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Categorized According to the Napping Habits for All Participants at Week 36 | Sometimes | 9 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 1
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 1
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 1 | Morning | 39 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 1 | Afternoon | 31 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 1 | Night | 15 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 1 | Participant did not take medication in this week | 1 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 12
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 12
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 12 | Morning | 21 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 12 | Afternoon | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 12 | Night | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 12 | Participant did not take medication in this week | 22 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 18
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 18
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 18 | Morning | 19 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 18 | Afternoon | 9 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 18 | Night | 6 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 18 | Participant did not take medication in this week | 24 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 24
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 24
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 24 | Morning | 12 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 24 | Afternoon | 8 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 24 | Night | 12 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 24 | Participant did not take medication in this week | 13 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 30
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 30
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 30 | Morning | 12 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 30 | Afternoon | 9 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 30 | Night | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 30 | Participant did not take medication in this week | 14 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 36
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 36
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 36 | Morning | 10 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 36 | Afternoon | 8 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 36 | Night | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 36 | Participant did not take medication in this week | 16 Participants |
Primary
Number of Participants Classified According to Time of Taking Treatment at Week 6
In this outcome measure, the number of participants were classified on the basis of the time of taking the oral medication - morning, afternoon or night. Morning was anytime between 7 am to 12 pm. Afternoon was anytime between 1 pm and 7 pm. Night was anytime between 8 pm to 6 am. Participants who did not take medication were also classified.
Time frame: Week 6
Population: Analysis population included all eligible participants who were included in this study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 6 | Morning | 19 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 6 | Afternoon | 13 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 6 | Night | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants Classified According to Time of Taking Treatment at Week 6 | Participant did not take medication in this week | 43 Participants |
Primary
Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1)
Best response was recorded from start of treatment with TKI until best complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP) was achieved. RECIST v1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions \[TLs\]) or non-target lesions (non-TLs) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs; b) PR: \>=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters; c) DP: \>=20% increase in sum of diameter of all TLs, taking as reference the smallest sum on study (including baseline measurement), sum must also be absolute increase of \>=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion; d) SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for PD referring smallest sum diameter. Participant whose best response was not determined were classified as Undetermined.
Time frame: From start of treatment with TKI until first documented best response of CR, PR, SD or DP (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) | CR | 0 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) | PR | 42 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) | SD | 29 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) | DP | 28 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Best Response Per Response Evaluation Criteria for Solid Tumours Version 1.1. (RECIST v1.1) | Undetermined | 12 Participants |
Primary
Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with fatigue event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4.
Time frame: During 9 months
Population: Analysis population included all eligible participants who were included in this study. Here, Overall Number of Participants Analyzed signifies participants with fatigue event.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Grade 1-2 | 6 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Fatigue Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Grade 3-4 | 0 Participants |
Primary
Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with hand foot syndrome event were classified into following: CTCAE grade 1 to 2 and CTCAE grade 3 to 4.
Time frame: During 9 months
Population: Analysis population included all eligible participants who were included in this study. Here, Overall Number of Participants Analyzed signifies participants with hand foot syndrome event.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Grade 1-2 | 30 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Hand Foot Syndrome Event Graded Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Grade 3-4 | 2 Participants |
Primary
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 12 are reported.
Time frame: Week 12
Population: Analysis population included all eligible participants who were included in this study. Here, 'Overall Number of Participants Analyzed' signifies participants with HFS event at Week 12.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 | Grade 1 | 11 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 | Grade 2 | 7 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 12 | Grade 3 | 1 Participants |
Primary
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 24 are reported.
Time frame: Week 24
Population: Analysis population included all eligible participants who were included in this study. Here, 'Overall Number of Participants Analyzed' signifies participants with HFS event at Week 24.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 | Grade 1 | 11 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 | Grade 2 | 2 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 24 | Grade 3 | 1 Participants |
Primary
Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. In this outcome measure number of participants with HFS event graded per CTCAE version 4.0 at Week 36 are reported.
Time frame: Week 36
Population: Analysis population included all eligible participants who were included in this study. Here, 'Overall Number of Participants Analyzed' signifies participants with HFS event at Week 36.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 | Grade 1 | 8 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 | Grade 2 | 1 Participants |
| Tyrosine Kinase Inhibitor | Number of Participants With Palmar-Plantar Erythrodysaesthesia (HFS) Event Graded Per CTCAE Version 4.0 at Week 36 | Grade 3 | 1 Participants |
Primary
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved CR or PR. Per RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (target lesions or non-target lesions) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs; b) PR: \>=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Time frame: From start of treatment with TKI until first documented CR or PR (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tyrosine Kinase Inhibitor | Objective Response Rate (ORR) | 37.8 Percentage of participants |
Primary
Progression-Free Survival (PFS)
PFS was defined as the time from the start of treatment with a TKI to tumour progression or death for any reason. Participants who, did not had the event were censored on the date of their final follow-up. Per RECIST v1.1, tumour progression: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion.
Time frame: From start of treatment with a TKI to tumour progression or death for any reason or till follow-up in case of no event (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tyrosine Kinase Inhibitor | Progression-Free Survival (PFS) | 9.3 Months |
Primary
Time to Treatment Failure (TTF) After Initiation of Tyrosine Kinase Inhibitor Therapy
TTF was defined as the time from the start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause. Participants who did not had the event were censored on the date of their final follow-up. Per RECIST 1.1, tumour progression: \>=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum on study (including baseline measurement) of diameter of all target lesions, sum must also demonstrate an absolute increase of \>=5 mm. Unequivocal progression of existing non target lesions. Appearance of at least 1 new lesion.
Time frame: From start of treatment with a TKI to tumour progression, treatment discontinuation for any reason or death from any cause or till follow-up in case of no event (approximately maximum up to 3.8 years)
Population: Analysis population included all eligible participants who were included in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tyrosine Kinase Inhibitor | Time to Treatment Failure (TTF) After Initiation of Tyrosine Kinase Inhibitor Therapy | 6.9 Months |