Trial Outcomes & Findings for Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice (NCT NCT02533258)
NCT ID: NCT02533258
Last Updated: 2025-07-16
Results Overview
Recruitment status
COMPLETED
Target enrollment
13 participants
Primary outcome timeframe
From initiation of axitinib treatment up to the end of the study (up to 40 months)
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
Axitinib (INLYTA)
Participants diagnosed with advanced renal cell carcinoma (RCC) and received axitinib therapy as per routine clinical practice according to the label-packaging-dosing (LPD) under the physician's prescription were observed for 40 months.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Axitinib (INLYTA)
Participants diagnosed with advanced renal cell carcinoma (RCC) and received axitinib therapy as per routine clinical practice according to the label-packaging-dosing (LPD) under the physician's prescription were observed for 40 months.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Other
|
1
|
|
Overall Study
Economic factor
|
1
|
|
Overall Study
Progression of pleural effusion
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Baseline characteristics by cohort
| Measure |
Axitinib (INLYTA)
n=13 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From initiation of axitinib treatment up to the end of the study (up to 40 months)Population: Efficacy population included all the participants who were enrolled in the study.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=13 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Duration of Axitinib Treatment
|
15.2 months
95% Confidence Interval 13.32 • Interval 8.01 to 24.11
|
PRIMARY outcome
Timeframe: From initiation of axitinib treatment up to the end of the study (up to 40 months)Population: Efficacy population included all the participants who were enrolled in the study.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=13 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Mean Daily Dose of Axitinib
|
9.24 milligram
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)Population: Efficacy population included all the participants who were enrolled in the study.
ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than \[\<\]10 millimeter \[mm\] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=13 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Objective Response Rate (ORR)
|
7.69 percentage of participants
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)Population: Efficacy population included all the participants who were enrolled in the study. Here 'number of participants analyzed' signifies participants who achieved a confirmed CR or PR.
Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (\<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as \>=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=1 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Duration of Response
|
1 months
Upper and lower limits of 95% confidence interval were not estimable since only 1 participant had event and analyzed for this outcome measure.
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)Population: Efficacy population included all the participants who were enrolled in the study.
PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as \>=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=13 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Progression-Free Survival (PFS)
|
32.73 months
Interval 3.57 to
The upper limit of 95% confidence interval was not reached at the time of data cut-off.
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment up to end of the study (up to 40 months)Population: Safety population included all the enrolled participants who received at least one dose of the axitinib.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=13 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
11 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 participants
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment up to end of the study (up to 40 months)Population: Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=11 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 1
|
5 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 2
|
3 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 3
|
3 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 4
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 5
|
0 participants
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment up to end of the study (up to 40 months)Population: Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=11 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events (AEs)
|
8 participants
|
SECONDARY outcome
Timeframe: From initiation of axitinib treatment up to end of the study (up to 40 months)Population: Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Axitinib (INLYTA)
n=11 Participants
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Number of Participants Discontinued Due to Adverse Events (AEs)
|
1 partcicipants
|
Adverse Events
Axitinib (INLYTA)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Axitinib (INLYTA)
n=13 participants at risk
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Vascular disorders
Dissecting aortic aneurysm type B
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Oliguria
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Anuria
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Axitinib (INLYTA)
n=13 participants at risk
Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months.
|
|---|---|
|
Vascular disorders
Hypertension
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Hernia
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Dry eye
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest discomfort
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Periodontitis
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophagia
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
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 publications 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