Trial Outcomes & Findings for Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer (NCT NCT00387764)
NCT ID: NCT00387764
Last Updated: 2014-01-14
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
From Baseline to Follow-up (up to 6.230 years)
Results posted on
2014-01-14
Participant Flow
Participant milestones
| Measure |
Pazopanib 800 mg
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Pazopanib 800 mg
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Sponsor Terminated Study
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Other
|
2
|
|
Overall Study
Death
|
7
|
Baseline Characteristics
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 10.95 • n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage (HER)
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER/South East Asian HER
|
10 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Follow-up (up to 6.230 years)Population: All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
78 participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
27 participants
|
PRIMARY outcome
Timeframe: From Baseline to Follow-up (up to 6.230 years)Population: ATP Population
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
Grade 1
|
12 participants
|
|
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
Grade 2
|
33 participants
|
|
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
Grade 3
|
22 participants
|
|
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
Grade 4
|
7 participants
|
|
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
Grade 5
|
4 participants
|
PRIMARY outcome
Timeframe: From Baseline to Follow-up (up to 6.230 years)Population: ATS Population
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With Adverse Events Related to Investigational Product
|
70 participants
|
PRIMARY outcome
Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)Population: ATS Population
The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Median Time on Investigational Product
|
9.7 Months
Interval 3.5 to 20.2
|
PRIMARY outcome
Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)Population: ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.
Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
ALP, any grade increase, n=77
|
26 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
ALP, increase to Grade 3, n=77
|
2 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
ALP, increase to Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
ALT, any grade increase, n=78
|
39 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
ALT, increase to Grade 3, n=78
|
5 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
ALT, increase to Grade 4, n=78
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
AST, any grade increase, n=78
|
43 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
AST, increase to Grade 3, n=78
|
5 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
AST, increase to Grade 4, n=78
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Creatinine, any grade increase, n=77
|
26 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Creatinine, increase Grade 3, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Creatinine, increase Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypercalcemia, any grade increase, n=71
|
14 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypercalcemia, increase to Grade 3, n=71
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypercalcemia, increase to Grade 4, n=71
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyperglycemia, any grade increase, n=77
|
46 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyperglycemia, increase to Grade 3, n=77
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyperglycemia, increase to Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyperkalemia, any grade increase, n=77
|
28 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyperkalemia, increase to Grade 3, n=77
|
4 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyperkalemia, increase to Grade 4, n=77
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypermagnesemia, any grade increase, n=77
|
15 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypermagnesemia, increase to Grade 3, n=77
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypermagnesemia, increase to Grade 4, n=77
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypernatremia, any grade increase, n=77
|
9 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypernatremia, increase to Grade 3, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypernatremia, increae to Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypocalcemia, any grade increase, n=71
|
30 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypocalcemia, increase to Grade 3, n=71
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypocalcemia, increase to Grade 4, n=71
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypoglycemia, any grade increase, n=77
|
12 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypoglycemia, increase to Grade 3, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypoglycemia, increase to Grade 4, n=77
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypokalemia, any grade increase, n=77
|
15 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypokalemia, increase to Grade 3, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypokalemia, increase to Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypomagnesemia, any grade increase, n=77
|
17 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypomagnesemia, increase to Grade 3, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hypomagnesemia, increase Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyponatremia, any grade increase, n=77
|
29 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyponatremia, increase to Grade 3, n=77
|
6 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Hyponatremia, increase to Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Phosphate, any grade increase, n=77
|
32 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Phosphate, increase to Grade 3, n=77
|
3 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
Phosphate, increase to Grade 4, n=77
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
TB, any grade increase, n=77
|
40 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
TB, increase to Grade 3, n=77
|
4 participants
|
|
Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline
TB, increase to Grade 4, n=77
|
0 participants
|
PRIMARY outcome
Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)Population: ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.
Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC \[leukopenia\]), and prothrombin time international normalized ratio (PT \[INR\]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Hemoglobin, any grade increase, n=78
|
29 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Hemoglobin, increase to Grade 3, n=78
|
2 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Hemoglobin, increas to Grade 4, n=78
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
INR (PT), any grade increase, n=67
|
10 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
INR (PT), increase to Grade 3, n=67
|
2 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
INR (PT), increase to Grade 4, n=67
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Lymphocytes, any grade increase, n=78
|
34 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Lymphocytes, increase to Grade 3, n=78
|
7 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Lymphocytes, increase to Grade 4, n=78
|
2 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Neutrophils, any grade increase, n=78
|
29 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Neutrophils, increase to Grade 3, n=78
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Neutrophils, increase to Grade 4, n=78
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Platelets, any grade increase, n=78
|
31 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Platelets, increase to Grade 3, n=78
|
1 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
Platelets, increase to Grade 4, n=78
|
0 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
WBC, any grade increase, n=78
|
32 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
WBC, increase to Grade 3, n=78
|
2 participants
|
|
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
WBC, increase to Grade 4, n=78
|
0 participants
|
PRIMARY outcome
Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)Population: ATS Population
Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury \[mmHg\]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (\<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, \>=170 mmHg) was assessed.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
SBP, <90 mmHg
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
SBP, 90 to 139 mmHg
|
29 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
SBP, 140 to 169 mmHg
|
44 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
SBP, >=170 mmHg
|
6 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
DBP, <90 mmHg
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
DBP, 90 to 139 mmHg
|
32 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
DBP, 140 to 169 mmHg
|
46 participants
|
|
Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
DBP, >=170 mmHg
|
1 participants
|
PRIMARY outcome
Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)Population: ATS Population. Only those participants available at the specified time points were analyzed.
Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of \<44 bpm, 44 to 100 bpm, 101 to 120 bpm, and \>120 bpm was assessed.
Outcome measures
| Measure |
Pazopanib 800 mg
n=79 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline
Heart rate 101 to 120 bpm
|
12 participants
|
|
Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline
Heart rate>120 bpm
|
1 participants
|
|
Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline
Heart rate <44 bpm
|
0 participants
|
|
Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline
Heart rate 44 to 100 bpm
|
66 participants
|
PRIMARY outcome
Timeframe: From Baseline to investigational product discontinuation (up to 6.230 years)Population: ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett's formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett's QTc value) were summarized using the following reference ranges: \<450, 450 to 479, 480 to 499, 500 to 549, and \>550 milliseconds.
Outcome measures
| Measure |
Pazopanib 800 mg
n=77 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Remained or reduced to <450
|
63 participants
|
|
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Remained at Baseline level of 450-479
|
2 participants
|
|
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Increased to 450-479
|
8 participants
|
|
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Increased to 480-499
|
3 participants
|
|
Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value
Increased to >=500
|
1 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)Population: ATS Population
Overall tumor response is defined as the number of participants achieving either a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). RECIST guidelines were used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. CR is defined as the disappearance of all target and non-target lesions, and PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as a reference the Baseline sum LD, as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With a Complete Response (CR) or Partial Response (PR)
CR
|
0 participants
|
|
Number of Participants With a Complete Response (CR) or Partial Response (PR)
PR
|
30 participants
|
|
Number of Participants With a Complete Response (CR) or Partial Response (PR)
CR+PR
|
30 participants
|
SECONDARY outcome
Timeframe: From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)Population: ATS Population. An analysis was performed on 71 participants.
The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.
Outcome measures
| Measure |
Pazopanib 800 mg
n=71 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)
|
35 participants
|
SECONDARY outcome
Timeframe: From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)Population: ATS Population
The best overall response is defined as the best response recorded from the start of the treatment until disease progression (PD)/recurrence. Per RECIST: CR, the disappearance of all target and non-target lesions; PR, at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; SD, neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s); PD, at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of \>=1 new lesion and/or unequivocal progression of existing non-target lesions. Unknown/not evaluable is used for those participants who cannot be classified as achieving CR, PR, SD, or PD.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Number of Participants With the Indicated Best Overall Response
Complete Response
|
0 participants
|
|
Number of Participants With the Indicated Best Overall Response
Partial Response
|
30 participants
|
|
Number of Participants With the Indicated Best Overall Response
Stable Disease
|
31 participants
|
|
Number of Participants With the Indicated Best Overall Response
Progressive Disease
|
10 participants
|
|
Number of Participants With the Indicated Best Overall Response
Unknown/Not Evaluable
|
9 participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)Population: ATS Population
PFS is defined as the interval between the date of the first dose of study medication and the date of disease progression as defined by the investigator or death due to any cause. RECIST was used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of \>=1 new lesion and/or unequivocal progression of existing non-target lesions. Participants who did not have disease progression or did not die were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Progression-free Survival (PFS)
|
9.2 months
Interval 7.3 to 12.0
|
SECONDARY outcome
Timeframe: From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)Population: ATS Population
OS is defined as the interval between the date of the first dose of study medication to the date of death due to any cause. For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Overall Survival (OS)
|
23.5 months
Interval 16.3 to 28.0
|
SECONDARY outcome
Timeframe: From the first dose of study medication to Month 12Population: ATS Population
For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.
Outcome measures
| Measure |
Pazopanib 800 mg
n=80 Participants
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Percentage of Participants Who Survived Until Month 12
|
72 Percentage of participants
|
Adverse Events
Pazopanib 800 mg
Serious events: 27 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pazopanib 800 mg
n=80 participants at risk
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
General disorders
Pain
|
2.5%
2/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Sudden death
|
2.5%
2/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Asthenia
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Oedema peripheral
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Bone abscess
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Bronchitis
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Infection
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Pneumonia
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Hepatobiliary disorders
Jaundice
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Electrocardiogram QT prolonged
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Nervous system disorders
Brachial plexopathy
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Injury, poisoning and procedural complications
Cataract
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Psychiatric disorders
Depression
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Vascular disorders
Hypertension
|
1.2%
1/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
Other adverse events
| Measure |
Pazopanib 800 mg
n=80 participants at risk
Participants received pazopanib 800 milligrams (mg) once daily.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
35/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
20/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
15/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
15/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Stomatitis
|
7.5%
6/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
4/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
43.8%
35/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
12/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.8%
7/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
7/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Vascular disorders
Hypertension
|
43.8%
35/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Fatigue
|
18.8%
15/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Asthenia
|
11.2%
9/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Chest pain
|
8.8%
7/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Mucosal inflammation
|
7.5%
6/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
General disorders
Pain
|
5.0%
4/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
12/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
10/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Weight decreased
|
12.5%
10/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
7.5%
6/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Blood bilirubin increased
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.0%
24/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Nervous system disorders
Headache
|
16.2%
13/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Nervous system disorders
Dysgeusia
|
12.5%
10/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Nervous system disorders
Dizziness
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
6/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
4/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
4/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Renal and urinary disorders
Proteinuria
|
13.8%
11/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
10/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
8/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Infections and infestations
Urinary tract infection
|
5.0%
4/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Psychiatric disorders
Insomnia
|
7.5%
6/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
5/80 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER