Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery (NCT NCT01575548)
NCT ID: NCT01575548
Last Updated: 2025-11-14
Results Overview
Disease-free survival (DFS) is defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
Assessed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually up to 6 years
Results posted on
2025-11-14
Participant Flow
The study was activated on August 8, 2012 and closed to accrual on July 25, 2017, with a total enrollment of 129 patients.
Participant milestones
| Measure |
Arm A (Pazopanib)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
63
|
|
Overall Study
Received Protocol Therapy
|
63
|
61
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
40
|
33
|
Reasons for withdrawal
| Measure |
Arm A (Pazopanib)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Placebo)
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
2
|
|
Overall Study
Disease progression
|
12
|
25
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other complicating disease
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Noncompliance
|
1
|
0
|
|
Overall Study
Anticipated surgery
|
0
|
1
|
|
Overall Study
Never started protocol therapy
|
3
|
2
|
Baseline Characteristics
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Baseline characteristics by cohort
| Measure |
Arm B (Placebo)
n=63 Participants
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=129 Participants
Total of all reporting groups
|
Arm A (Pazopanib)
n=66 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=10 Participants
|
60 years
n=20 Participants
|
60 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=10 Participants
|
48 Participants
n=20 Participants
|
21 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=10 Participants
|
81 Participants
n=20 Participants
|
45 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=10 Participants
|
121 Participants
n=20 Participants
|
60 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=10 Participants
|
118 Participants
n=20 Participants
|
61 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually up to 6 yearsPopulation: All randomized patients are included in this analysis.
Disease-free survival (DFS) is defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause.
Outcome measures
| Measure |
Arm A (Pazopanib)
n=66 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Placebo)
n=63 Participants
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease-free Survival (DFS)
|
17 months
Interval 14.0 to 20.4
|
14.2 months
Interval 9.1 to 23.5
|
SECONDARY outcome
Timeframe: Assessed every 3 months for the first 2 years, and then every 6 months for the 3rd year.Population: All randomized patients are included in this analysis.
Overall survival is defined as the time from randomization to death or date last known alive. Kaplan-Meier method was used to estimate 3-year overall survival rate.
Outcome measures
| Measure |
Arm A (Pazopanib)
n=66 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Placebo)
n=63 Participants
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
3-year Overall Survival (OS) Rate
|
0.816 proportion of participants
Interval 0.712 to 0.935
|
0.889 proportion of participants
Interval 0.798 to 0.99
|
SECONDARY outcome
Timeframe: Assessed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually up to 10 yearsOS for each arm is divided into 3 health states: toxicity (TOX), time without symptoms of disease or toxicity (TWiST), and recurrence (REC). TOX is defined as the time spent with grade 3/4 adverse events (AEs) prior to disease recurrence. TWiST is defined as the time prior to disease recurrence when no AEs of grade 3/4 were experienced. REC health state is defined as the time from disease recurrence or second primary cancer until death. Patients alive will be censored at the date of last contact. For each health state, a patient-reported utility weight will be assigned. The mean amount of time in each state will be estimated using Kaplan and Meier method. TWiST = mean recurrence-free survival (RFS) - mean time with toxicities REC = mean OS - mean RFS Q-TWiST = (uTOX x TOX) + (uTWiST x TWiST) + (uREC x REC) Where uTOX, uTWiST, and uREC represent the average group utility value for each state for that arm and TOX, TWiST and REC represent the mean duration of the state for that arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at baseline and 6 monthsFACIT-Fatigue subscale (13 items) was used to evaluate fatigue in this patient population. The score ranges between 0 and 52. The higher the score, the better the quality of life. The change in FACIT-Fatigue score from baseline to 6 months will be compared between the two arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at baseline and 6 monthsFunctional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 15 Item Version (FKSI-15) will be used to evaluate the quality of life concerns among this patient population. The change in score from baseline to 6 months will be compared between the two arms. The score ranges between 0 and 60. A score of "0" is a severely symptomatic patient and the highest possible score is an asymptomatic patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at baseline and cycle 2 day 1Plasma concentration of pazopanib will be assessed at baseline and cycle 2 day 1.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
Adverse Events
Arm A (Pazopanib)
Serious events: 43 serious events
Other events: 62 other events
Deaths: 15 deaths
Arm B (Placebo)
Serious events: 14 serious events
Other events: 49 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A (Pazopanib)
n=63 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Placebo)
n=61 participants at risk
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
General disorders
Fatigue
|
4.8%
3/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
General disorders
General disorders and administration site conditions - Other
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Diarrhea
|
15.9%
10/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Jejunal hemorrhage
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Jejunal ulcer
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Infections and infestations
Abdominal infection
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Infections and infestations
Lung infection
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
9/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Aspartate aminotransferase increased
|
7.9%
5/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Lipase increased
|
6.3%
4/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
3.3%
2/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Lymphocyte count decreased
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Neutrophil count decreased
|
3.2%
2/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Serum amylase increased
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Weight loss
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
White blood cell decreased
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
3.3%
2/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
2/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.6%
1/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
2/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Vascular disorders
Hypertension
|
31.7%
20/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
6.6%
4/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
Other adverse events
| Measure |
Arm A (Pazopanib)
n=63 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Placebo)
n=61 participants at risk
Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
General disorders
Fatigue
|
61.9%
39/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
32.8%
20/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
9/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
3.3%
2/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.0%
12/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
6.6%
4/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
11.1%
7/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
14/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
9.8%
6/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Diarrhea
|
65.1%
41/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
23.0%
14/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Nausea
|
58.7%
37/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
24.6%
15/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
18/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
3.3%
2/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Alanine aminotransferase increased
|
38.1%
24/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
13.1%
8/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Aspartate aminotransferase increased
|
31.7%
20/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
11.5%
7/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Blood bilirubin increased
|
11.1%
7/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
0.00%
0/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Lymphocyte count decreased
|
19.0%
12/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
3.3%
2/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Neutrophil count decreased
|
19.0%
12/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
Platelet count decreased
|
39.7%
25/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
6.6%
4/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Investigations
White blood cell decreased
|
30.2%
19/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
1.6%
1/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.8%
15/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
6.6%
4/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.5%
11/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
18.0%
11/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
3/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
6.6%
4/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.9%
10/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
6.6%
4/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Nervous system disorders
Dizziness
|
9.5%
6/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
16.4%
10/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Nervous system disorders
Headache
|
44.4%
28/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
19.7%
12/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Renal and urinary disorders
Proteinuria
|
22.2%
14/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
16.4%
10/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
|
Vascular disorders
Hypertension
|
65.1%
41/63 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
42.6%
26/61 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Serious adverse events (SAEs) are defined as AEs of grade 3 or higher that are possibly, probably, or definitely related to protocol treatment. Other AEs are defined as those adverse events of grade 1 or grade 2 that are possibly, probably, or definitely related to protocol treatment with a frequency of at least 5% in a given arm. All randomized patients were included in the all-cause mortality table. Only patients who received assigned treatment were included in the SAE and other AE tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60