Trial Outcomes & Findings for A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA) (NCT NCT04115189)
NCT ID: NCT04115189
Last Updated: 2022-05-10
Results Overview
Recruitment status
COMPLETED
Target enrollment
57 participants
Primary outcome timeframe
During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
Results posted on
2022-05-10
Participant Flow
Participants who were diagnosed with metastatic renal cell carcinoma (mRCC), as per customized retrospective medical record review conducted in 7 countries (Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, and Peru) from January 2014 to June 2018 (+/- 6 months, maximum up to 5 years), and treated with Sunitinib, were included in this study and their data was observed retrospectively.
The index date was the date of switching first-line treatment from 4/2 administration schedule (4 weeks sunitinib treatment followed by 2 weeks off treatment) to 2/1 administration schedule (2 weeks sunitinib treatment followed by 1 week off treatment) or initiating first-line treatment on the 2/1 schedule.
Participant milestones
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
15
|
|
Overall Study
COMPLETED
|
42
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 39 years
|
1 Participants
n=42 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=57 Participants
|
|
Age, Customized
40 to 49 years
|
6 Participants
n=42 Participants
|
1 Participants
n=15 Participants
|
7 Participants
n=57 Participants
|
|
Age, Customized
50 to 59 years
|
15 Participants
n=42 Participants
|
6 Participants
n=15 Participants
|
21 Participants
n=57 Participants
|
|
Age, Customized
60 to 69 years
|
15 Participants
n=42 Participants
|
4 Participants
n=15 Participants
|
19 Participants
n=57 Participants
|
|
Age, Customized
>=70 years
|
5 Participants
n=42 Participants
|
0 Participants
n=15 Participants
|
5 Participants
n=57 Participants
|
|
Age, Customized
Unknown
|
0 Participants
n=42 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=57 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=42 Participants
|
3 Participants
n=15 Participants
|
26 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=42 Participants
|
12 Participants
n=15 Participants
|
31 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1983
|
0 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1937
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1939
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1942
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1943
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1944
|
1 Participants
|
2 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1946
|
1 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1947
|
2 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1948
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1949
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1950
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1951
|
2 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1952
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1953
|
5 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1954
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1955
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1956
|
1 Participants
|
2 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1957
|
4 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1958
|
2 Participants
|
2 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1959
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1960
|
0 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1963
|
1 Participants
|
2 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1965
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1966
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1968
|
0 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1969
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1975
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Year of Birth
Year: 1978
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Data for participants with following comorbidities were observed and reported: cerebrovascular disease,chronic pulmonary disease,congestive heart failure,connective tissue disease,dementia,diabetes with end organ damage,diabetes without end organ damage,depression,hemiplegia or paraplegia, history of myocardial infarction,human immunodeficiency virus/ acquired immunodeficiency syndrome,hypertension,mild liver disease (i.e., chronic hepatitis or cirrhosis without portal hypertension),moderate to severe liver disease (i.e., cirrhosis and portal hypertension),use of warfarin,moderate to severe renal disease (i.e., creatinine \>3mg% \[265 mcmol/l\],dialysis,transplantation,uremic syndrome),ulcer disease,peripheral vascular disease,skin ulcers/cellulitis,horseshoe kidney,polycystic kidney disease,von hippel-lindau disease,chronic viral hepatitis, previous thyroid disorders. Categories with at least 1 non-zero data are reported below. One participant could have more than 1 comorbidities.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Demographic Characteristic of Participants: Comorbidities
Cerebrovascular disease
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Congestive heart failure
|
1 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Diabetes with end organ damage
|
3 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Diabetes without end organ damage
|
7 Participants
|
5 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Depression
|
3 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
History of myocardial infarction
|
4 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Hypertension
|
27 Participants
|
10 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Mild liver disease
|
1 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Moderate to severe renal disease
|
2 Participants
|
0 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Horseshoe kidney
|
0 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Polycystic kidney disease
|
0 Participants
|
1 Participants
|
—
|
|
Demographic Characteristic of Participants: Comorbidities
Previous thyroid disorders
|
5 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Participants with following insurance status were observed and reported: Private insurance only and public insurance.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Demographic Characteristic of Participants: Primary Health Insurance Type
Public health plan
|
11 Participants
|
7 Participants
|
—
|
|
Demographic Characteristic of Participants: Primary Health Insurance Type
Private health plan
|
31 Participants
|
6 Participants
|
—
|
|
Demographic Characteristic of Participants: Primary Health Insurance Type
Unknown
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=21 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=8 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Demographic Characteristic of Participants: Height
|
164.4 Centimeter
Standard Deviation 10.4
|
168.9 Centimeter
Standard Deviation 6.6
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=28 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=8 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Demographic Characteristic of Participants: Weight
|
73.5 Kilograms
Standard Deviation 13.6
|
90.5 Kilograms
Standard Deviation 12.4
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Body mass index (BMI) is calculated as the body mass in kilograms divided by the square of the body height in meters.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=21 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=8 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Demographic Characteristic of Participants: Body Mass Index
|
28.2 Kilogram per square meter (kg/m^2)
Standard Deviation 5.7
|
31.8 Kilogram per square meter (kg/m^2)
Standard Deviation 4.4
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
In this outcome measure participants diagnosed with mRCC between 2012 to 2018 were reported.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2014
|
3 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2012
|
1 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2013
|
2 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2015
|
9 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2016
|
8 Participants
|
5 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2017
|
15 Participants
|
4 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Year: 2018
|
4 Participants
|
3 Participants
|
—
|
|
Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
Unknown
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
The American Joint Committee on Cancer (AJCC) stages were assigned. Stage I- defined as tumor of 7 cm across or smaller, while Stage II- defined as tumor larger than 7 cm across and did not spread to lymph nodes or distant organs, Stage III- defined as tumor was growing into a major vein (like the renal vein or the vena cava) or into tissue around the kidney, but it was not growing into the adrenal gland or beyond Gerota's fascia. There was no spread to lymph nodes or distant organs. Stage IV- defined as main tumor was growing beyond Gerota's fascia and may be growing into the adrenal gland on top of the kidney. It might or might not had spread to nearby lymph nodes. It had not spread to distant lymph nodes or other organs.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
Stage I
|
1 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
Stage II
|
6 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
Stage III
|
6 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
Stage IV
|
17 Participants
|
10 Participants
|
—
|
|
Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
Unknown
|
12 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, "number analyzed" signifies the number of participants evaluable at specific category.
Participants with Memorial Sloan Kettering Cancer Center(MSKCC)model and International Metastatic Renal Cell Carcinoma Database Consortium(IMDC)criteria risks groups are reported.MSKCC model assessed as low(0),intermediate(1-2) or high risk(=\>3)based on number of criteria present.Criteria=Karnofsky performance status(KPS)score \<80,lactate dehydrogenase\>1.5\*upper limit of normal,hemoglobin\<lower limit of normal, corrected serum calcium\>10 mg/dL,time from first diagnosis of RCC to start of systemic therapy of\<1 year.KPS score range:0=death to 100=no evidence of disease,higher score=higher ability to perform daily tasks.IMDC risk group stratifies participants in poor,intermediate(had 1 or 2 poor factors)and favorable(had no poor factors)risk groups based on number of adverse clinical,laboratory parameters.Poor factors included KPS score of\<80 at initiation of treatment,time from diagnosis to metastasis treatment of\<12 months,anemia,corrected calcium\>10 mg/dL,neutrophilia,thrombocythemia.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Clinical Characteristic of Participants: Risk Groups
MSKCC: Low risk
|
25 Participants
|
6 Participants
|
—
|
|
Clinical Characteristic of Participants: Risk Groups
MSKCC: Intermediate risk
|
12 Participants
|
7 Participants
|
—
|
|
Clinical Characteristic of Participants: Risk Groups
MSKCC: Poor risk
|
5 Participants
|
2 Participants
|
—
|
|
Clinical Characteristic of Participants: Risk Groups
IMDC: Favorable risk
|
4 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Risk Groups
IMDC: Intermediate risk
|
11 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Risk Groups
IMDC: Poor risk
|
2 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Number of participants with the sites of distant metastasis at initial metastatic diagnosis are reported in this outcome measure. Sites evaluated for distant metastasis were lymph nodes, bone, brain, liver, lung/pleura, adrenal gland, pancreas, others (peritoneum, surgical lodge, soft tissue, nephrectomy bed). One participant could have more than 1 sites of metastases.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Other: Surgical lodge
|
2 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Brain
|
3 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Liver
|
8 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Lung/pleura
|
25 Participants
|
8 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Lymph nodes
|
13 Participants
|
3 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Bone
|
10 Participants
|
2 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Adrenal gland
|
5 Participants
|
2 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Pancreas
|
2 Participants
|
2 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Other: Peritoneum
|
3 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Other: Soft tissue
|
2 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Sites of Distant Metastases
Other: Nephrectomy bed
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
The ECOG performance status was used to assess the effect of disease progression on participant's daily activities. ECOG performance status Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2: ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours, Grade 3: capable of only limited self-care, confined to bed or chair for more than 50% of waking hours, Grade 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
13 Participants
|
5 Participants
|
—
|
|
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
23 Participants
|
7 Participants
|
—
|
|
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
3 Participants
|
1 Participants
|
—
|
|
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Unknown
|
3 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Before diagnosis of mRCC, anytime during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
In this outcome measure participants with different treatment modalities including partial nephrectomy, radical nephrectomy, radiation therapy, neoadjuvant systemic therapy and adjuvant systemic therapy were reported. One participant could have more than 1 treatment modalities.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=28 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=9 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
Partial nephrectomy
|
1 Participants
|
0 Participants
|
—
|
|
Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
Radical nephrectomy
|
28 Participants
|
8 Participants
|
—
|
|
Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
Radiation therapy
|
0 Participants
|
0 Participants
|
—
|
|
Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
Neoadjuvant systemic therapy
|
0 Participants
|
1 Participants
|
—
|
|
Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
Adjuvant systemic therapy
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From last treatment received to mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
In this outcome measure the duration form last treatment received including: partial nephrectomy, radical nephrectomy, radiation therapy, neoadjuvant systemic therapy and adjuvant systemic therapy was reported.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=25 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=7 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
|
46.0 Months
Standard Deviation 50.3
|
59.1 Months
Standard Deviation 94.3
|
—
|
PRIMARY outcome
Timeframe: From date of metastatic diagnosis to end of data identification period, for a maximum of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Number of participants were classified and reported according to the number of treatment lines received including first-line, second-line and third-line or more after diagnosis of mRCC.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Three or more lines of treatment
|
7 Participants
|
1 Participants
|
—
|
|
Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
First -line treatment
|
15 Participants
|
14 Participants
|
—
|
|
Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Second-line treatment
|
20 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Duration between initiating and termination date of each treatment line received after mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, "number analyzed" signifies the number of participants evaluable at specific category.
This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
First-line treatment
|
12.3 Months
Interval 10.0 to 14.0
|
37.5 Months
Interval 7.5 to
Upper limit for 95% CI could not be estimated because there were insufficient number of participants with event.
|
—
|
|
Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Second-line treatment
|
6.5 Months
Interval 5.0 to 9.9
|
NA Months
Median and 95% CI could not be estimated because there were insufficient number of participants with event.
|
—
|
|
Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Third-line treatment
|
6.6 Months
Interval 2.9 to
Upper limit for 95% CI could not be estimated because there were insufficient number of participants with event.
|
NA Months
Median and 95% CI could not be estimated because there were insufficient number of participants with event.
|
—
|
PRIMARY outcome
Timeframe: Day 1 of sunitinib first line treatment to end date of sunitinib treatment, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Duration of Treatment With Sunitinib
|
4.6 Months
Standard Deviation 3.7
|
7.5 Months
Standard Deviation 5.5
|
13.6 Months
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: End date of 4/2 sunitinib schedule and start date of 2/1 sunitinib schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.Data for this outcome measure is reported for evaluable participants in arm 4/2 to 2/1 schedule only.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Duration Between Discontinuation of 4/2 Schedule and Initiation of 2/1 Schedule
|
0.6 Months
Standard Deviation 0.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arm including 4/2 schedule only.
Number of participants with their reasons for switching to 2/1 schedule treatment including adverse event, local or professional protocol, participant decision, performance status and other (renal function deterioration; medical decision, site of cytoreductive surgery), were reported. One participant could have multiple reasons to switch to 2/1 treatment schedule.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Adverse event
|
31 Participants
|
—
|
—
|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Local or professional protocol
|
2 Participants
|
—
|
—
|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Participant decision
|
1 Participants
|
—
|
—
|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Performance status
|
10 Participants
|
—
|
—
|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Other: Renal function deterioration
|
1 Participants
|
—
|
—
|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Other: Medical decision, site of cytoreductive surgery
|
1 Participants
|
—
|
—
|
|
Participants With Reasons for Switching to 2/1 Treatment Schedule
Unknown
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date to end date of 2/1 treatment schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. Data for this outcome measure is reported for evaluable participants in arms including 4/2 to 2/1 schedule only.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Duration of Sunitinib 2/1 Treatment Schedule After Switching From 4/2 Treatment Schedule
|
6.7 Months
Interval 6.0 to 10.3
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date to end date of sunitinib 2/1 schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Participants who had a termination of sunitinib treatment for reasons other than regimen change or switch, disease progression, or death were reported as discontinued. Categories with at least 1 non-zero data are reported below. One participant could have more than 1 reason for discontinuation.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=38 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=9 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Adverse event
|
4 Participants
|
0 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Participant decision
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Progressive disease
|
26 Participants
|
2 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Performance status
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Lost to follow-up
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Death
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Unknown
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
Other
|
2 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Number of Participants With At-least 1 Dose Change
|
4 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
Participants who had change in the dose of sunitinib during the data identification period were reported. Categories with at least 1 non-zero data are reported below.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=4 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=3 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=2 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Number of Participants With Reason For Dose Change
Adverse event
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Reason For Dose Change
Adherence
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Index date up to end of follow up, disease progression, death, whichever occurred first during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Best response includes complete response (CR): equal to disappearance of all target lesions; partial response (PR): greater than equal to (\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions; progressive disease (PD): \>=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>=1 new lesion; stable disease (SD): neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start; as well as response not assessed and unknown also reported.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Complete response
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Partial response
|
14 Participants
|
5 Participants
|
—
|
|
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Stable disease
|
17 Participants
|
2 Participants
|
—
|
|
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Progressive disease
|
5 Participants
|
3 Participants
|
—
|
|
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Response not assessed
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
Unknown
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arms including 4/2 schedule only.
Number of participants with different supportive care including anticoagulants, antibiotics, antidepressants, antidiarrheal, antiemetics, antifungals, antihistamines, antihypertensive medication, erythropoiesis stimulating agents (ESAs), granulocyte colony-stimulating factor (GSCF), hormone replacement, iron supplements, nutritional supplements, pain medications, platelet transfusion, red blood cell transfusion, steroids, topical skin care lotions/creams/moisturizers, other (pantoprazole) were reported. One participant could have more than 1 supportive care elements.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Anticoagulants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antibiotics
|
4 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antidepressants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antidiarrheal
|
26 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antiemetics
|
14 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antifungals
|
2 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antihistamines
|
1 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Antihypertensive medication
|
24 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
ESAs
|
2 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
GSCF
|
1 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Hormone replacement
|
5 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Iron supplements
|
4 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Nutritional supplements
|
4 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Pain medications
|
21 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Platelet transfusion
|
0 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Red blood cell transfusion
|
2 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Steroids
|
3 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Topical skin care lotions/creams/moisturizers
|
14 Participants
|
—
|
—
|
|
Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
Other: Pantoprazole
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of sunitinib first line treatment to follow up, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in all of three arms including 4/2 schedule, 4/2 to 2/1 schedule and 2/1 schedule.
An adverse event (AE) was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Adverse Events Observed During First-line Treatment With Sunitinib
Mild
|
42 Participants
|
42 Participants
|
14 Participants
|
|
Adverse Events Observed During First-line Treatment With Sunitinib
Moderate
|
30 Participants
|
24 Participants
|
11 Participants
|
|
Adverse Events Observed During First-line Treatment With Sunitinib
Severe
|
7 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Progression free survival (PFS) was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death case report forms (CRFs). This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Progression Free Survival (PFS) From Initial Metastatic Diagnosis
|
19.1 Months
Interval 15.0 to 25.2
|
NA Months
Interval 17.2 to
Median and upper limit of 95% CI were not estimable due insufficient number of participants with event.
|
—
|
PRIMARY outcome
Timeframe: From date of initiation of sunitinib 4/2 schedule to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arm including 4/2 schedule only.
PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death CRFs. This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Progression Free Survival (PFS) From Initiation of Sunitinib 4/2 Treatment Schedule
|
16.6 Months
Interval 12.5 to 23.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death CRFs. This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule
|
12 Months
Interval 6.5 to 17.7
|
NA Months
Interval 16.0 to
Median and Upper limit of 95% CI were not estimable due insufficient number of participants with event
|
—
|
PRIMARY outcome
Timeframe: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
Overall survival (OS) was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Overall Survival (OS) From Metastatic Diagnosis
|
46.1 Months
Interval 31.5 to
Upper limit of 95% CI was not estimable due insufficient number of participants with event.
|
NA Months
Interval 22.6 to
Median and upper limit of 95% CI were not estimable due insufficient number of participants with event.
|
—
|
PRIMARY outcome
Timeframe: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Data for this outcome measure is reported for evaluable participants in arm including 4/2 to 2/1 schedule only.
OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Overall Survival (OS) From Initiation of Sunitinib 4/2 Treatment Schedule
|
46.1 Months
Interval 29.1 to
Upper limit of 95% CI was not estimable due insufficient number of participants with event.
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed.
OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date participant alive. Kaplan-Meier method was used for OS analysis. This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule
|
42.0 Months
Interval 26.0 to
Upper limit of 95% CI was not estimable due insufficient number of participants with event.
|
NA Months
Interval 16.5 to
Median and upper limit of 95% CI were not estimable due insufficient number of participants with event.
|
—
|
PRIMARY outcome
Timeframe: From mRCC diagnosis to start date of second line treatment and from end date of first line treatment to start date of second line treatment,data identification period of 5 years(data recorded during approx. 12 months of retrospective observation period)Population: Analysis population included all eligible participants whose data were retrieved from medical records and assessed. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=27 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=1 Participants
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Time to Initiate Second Line Treatment
From mRCC diagnosis
|
19.7 Months
Standard Deviation 16.4
|
37.5 Months
Standard Deviation NA
Standard deviation was not estimable due insufficient number of participants with event.
|
—
|
|
Time to Initiate Second Line Treatment
From first-line discontinuation
|
2.6 Months
Standard Deviation 2.9
|
28.0 Months
Standard Deviation NA
Standard deviation was not estimable due insufficient number of participants with event.
|
—
|
Adverse Events
Sunitinib: Switched From 4/2 to 2/1 Schedule (4/2 Schedule)
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Sunitinib: Switched From 4/2 to 2/1 Schedule
Serious events: 5 serious events
Other events: 42 other events
Deaths: 20 deaths
Sunitinib 2/1 Schedule
Serious events: 0 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule (4/2 Schedule)
n=42 participants at risk
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 participants at risk
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 participants at risk
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
General disorders
Asthenia
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Fatigue
|
9.5%
4/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Pain
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Stomatitis
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Gastrointestinal disorders
Mucositis
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Vascular disorders
Hypertension
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
Other adverse events
| Measure |
Sunitinib: Switched From 4/2 to 2/1 Schedule (4/2 Schedule)
n=42 participants at risk
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib: Switched From 4/2 to 2/1 Schedule
n=42 participants at risk
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg per day on 4/2 schedule then switched to 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months) were observed retrospectively over a duration of approximately 12 months.
|
Sunitinib 2/1 Schedule
n=15 participants at risk
Participants with mRCC who initiated first-line treatment with sunitinib 50 mg on 2/1 schedule in the daily clinical practice, between 1-Jan-2014 and 30-Jun-2018 (+/- 6 months), were observed retrospectively over a duration of approximately 12 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
73.8%
31/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
78.6%
33/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
66.7%
10/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
12/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
31.0%
13/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
66.7%
10/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Gastrointestinal disorders
Dyspepsia
|
40.5%
17/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
31.0%
13/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
20.0%
3/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Gastrointestinal disorders
Mucositis
|
52.4%
22/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
59.5%
25/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.7%
4/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
18/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
35.7%
15/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
73.3%
11/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
8/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
21.4%
9/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.7%
4/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Asthenia
|
83.3%
35/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
73.8%
31/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
60.0%
9/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Changes in hair color
|
35.7%
15/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.2%
11/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
40.0%
6/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Chills
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Fatigue
|
38.1%
16/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
40.5%
17/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
60.0%
9/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Influenza-like illness
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Pain
|
42.9%
18/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
33.3%
14/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.7%
4/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Pyrexia
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
9.5%
4/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
General disorders
Stomatitis
|
33.3%
14/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
28.6%
12/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
20.0%
3/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
21/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
42.9%
18/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
53.3%
8/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Nervous system disorders
Dysgeusia
|
31.0%
13/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
31.0%
13/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
0.00%
0/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
14.3%
6/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
33.3%
5/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Vascular disorders
Hypertension
|
54.8%
23/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
54.8%
23/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
40.0%
6/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Endocrine disorders
Hypothyroidism
|
23.8%
10/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
28.6%
12/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
20.0%
3/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Cardiac disorders
Decline in ejection fraction
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
9.5%
4/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
26.2%
11/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
38.1%
16/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
40.0%
6/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
50.0%
21/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
45.2%
19/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
46.7%
7/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
9.5%
4/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.7%
4/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
26.2%
11/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
21.4%
9/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.7%
4/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Investigations
CPK increased
|
9.5%
4/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
13.3%
2/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
10/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
16.7%
7/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
53.3%
8/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.9%
5/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
16.7%
7/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
20.0%
3/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
7/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
9.5%
4/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
26.7%
4/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Investigations
Lipase increased
|
14.3%
6/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
13.3%
2/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
6/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.0%
8/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
14.3%
6/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
18/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
42.9%
18/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
33.3%
5/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.9%
5/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
7.1%
3/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Hepatobiliary disorders
Liver toxicity
|
4.8%
2/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
6.7%
1/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
|
Renal and urinary disorders
Renal toxicity
|
2.4%
1/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
11.9%
5/42 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
13.3%
2/15 • From 01-Jan-2014 to 30-Jun-2018 (+/- 6 months), for a maximum of 5 years (data recorded during 12 months of retrospective observation period)
Same event may appear as both an AE and a serious AE. 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. No source vocabulary name used for adverse event reporting', because of the retrospective nature of the study and physicians were asked to report evidence of AE as: mild, moderate, or severe.
|
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