Trial Outcomes & Findings for Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST) (NCT NCT01391611)
NCT ID: NCT01391611
Last Updated: 2017-04-07
Results Overview
4-mo non-progression rate "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Pazopanib Arm
Pazopanib: 800 mg; PO
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST)
Baseline characteristics by cohort
| Measure |
Pazopanib Arm
n=25 Participants
Pazopanib: 800 mg; PO
|
|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 weeks4-mo non-progression rate "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
Outcome measures
| Measure |
Pazopanib Arm
n=25 Participants
Pazopanib: 800 mg; PO
|
|---|---|
|
Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)
|
1.9 months
Interval 1.6 to 5.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Choi criteria measurements were not done due to technical difficulties.
Response per Choi criteria * Complete response - Disappearance of all lesions; no new lesion * Partial response - A decrease in size of \> or = 10% or a decrease in tumor density (HU) \> or = 15% on CT. No new lesions. No obvious progression of nonmeasurable disease. * Stable disease - Does not meet the criteria for CR, PR, or PD. No symptomatic deterioration attributed to tumor progression. * Progressive disease - An increase in tumor size of \> or = 10% and does not meet criteria of PR by tumor density (HU) on CT. New lesions. New intratumoral nodules or increase in the size of the existing intratumoral nodules.
Outcome measures
| Measure |
Pazopanib Arm
Pazopanib: 800 mg; PO
|
|---|---|
|
Response Per Choi Criteria
|
0
|
Adverse Events
Pazopanib Arm
Serious events: 14 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pazopanib Arm
n=25 participants at risk
Pazopanib: 800 mg; PO
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsened shortness of breath
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Worsened ascites G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Vascular disorders
Deep venous thrombosis G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Worsened right pleural effusion G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
General disorders and administration site conditions-other, specify, Disease progression-fatal G5
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Constipation G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
GI disorders-other, E. coli bacteremia G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intestinal perforation G4
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Fatigue G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Sacral decubitus G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Ascites G3
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Nervous system disorders
Peripheral motor neuropathy G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Nervous system disorders
Seizure G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Hepatobiliary disorders
Nonviral hepatitis/transaminitis G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Anemia G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Worsening fatigue G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Abdominal pain G3
|
8.0%
2/25 • Number of events 4 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Dehydration G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Renal failure G5
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
GI Bleed G3
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Rectal hemorrhage, rectum bleeding
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
GI Bleed G5
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Nervous system disorders
Cognitive disturbance G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Acute pancreatitis G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
Blood bilirubin increased G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
Alkaline phosphatase increased G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
AST incresed G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
ALT increased G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
GGT increased G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
Other adverse events
| Measure |
Pazopanib Arm
n=25 participants at risk
Pazopanib: 800 mg; PO
|
|---|---|
|
Gastrointestinal disorders
Vomiting G1
|
24.0%
6/25 • Number of events 6 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent vomiting G1
|
16.0%
4/25 • Number of events 4 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Vomiting G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Vomiting G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Fatigue G1
|
20.0%
5/25 • Number of events 7 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Fatigue G2
|
32.0%
8/25 • Number of events 8 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent nausea G1
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Nausea G1
|
24.0%
6/25 • Number of events 7 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Nausea G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Nausea G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Worsened back pain G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain right G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Nervous system disorders
Loss of consciousness, transient G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Bilateral femur pain
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Reproductive system and breast disorders
Vaginal bleeding G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Urinary tract infection G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Worsened DOE G1
|
4.0%
1/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Hyperkalemia G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Worsened anemia G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Worsened anemia G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Worsening anemia G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Anemia (secondary to GI bleed) G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Neutropenia G2
|
8.0%
2/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent worsened abdominal pain w/ radiation to R shoulder G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Intermittent back pain G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Worsened low back pain with radiation to buttocks, R hip G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Acute lower back pain G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent diarrhea G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Diarrhea G1
|
36.0%
9/25 • Number of events 9 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent constipation G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Constipation G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Decreased appetite G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Decreased appetite G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Anorexia G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent cramps abdomen G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Intermittent cramps, feet
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Intermittent pain/cramps legs G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Pain elbow G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Early satiety G1
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Intermittent night sweats G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Hemorrhoids G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Facial flushing G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Generalized depigmentation G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Decreased strength G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory symptoms G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Weakness lower extremities G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Generalized weakness G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Weight loss G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Leukopenia G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Vascular disorders
Hypertension G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Vascular disorders
Hypertension G2
|
24.0%
6/25 • Number of events 7 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Vascular disorders
Hypertension G3
|
12.0%
3/25 • Number of events 4 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis G1
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Constipation G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Pain B/L legs R>L G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Decreased urine output
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Leukopenia G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Fever G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Abdominal cramping G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent postprandial cramping G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent abdominal pain G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Abdominal pain G1
|
16.0%
4/25 • Number of events 4 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Left lower abdominal and lower back pain
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Abdominal pain G2
|
20.0%
5/25 • Number of events 6 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Pain G2
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Worsened LUQ pain G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Axorexia G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Nervous system disorders
Headache G1
|
24.0%
6/25 • Number of events 6 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Nervous system disorders
Headache G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Hand/foot syndrome
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Joint and muscle pain G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Intermittent right shoulder pain G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Worsening pain G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Left wrist pain with cellulitis
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Lower back and left calf pain G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Intermittent leg cramps G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps (pain) G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Intermittent sore mouth G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Mouth pain G1
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Oral dysesthesia G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea and throat discomfort
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Infections and infestations
Thrush (mucosal infection) G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Infections and infestations
oral candidiasis G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Dysgeusia G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Hypomagnesemia G1
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Cystitis G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Proteinuria G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Proteinuria G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Renal and urinary disorders
Elevated UPC G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
Blood bilirubin increased G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
Blood bilirubin increased G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
Alkaline phosphatase increased G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
GGT increased G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
ALT increased G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
AST increased G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
AST increased G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
Alkaline phosphatase increased G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Investigations
GGT increased G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Ascites G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Rash G1
|
12.0%
3/25 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Facial and hand edema G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Infection - rash G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Skin irritation - perianal G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation B/L forearms G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Skin dryness G1
|
8.0%
2/25 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Whitening of hair G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Skin and subcutaneous tissue disorders
Hair lightening G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Psychiatric disorders
Anxiety G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Psychiatric disorders
Insomnia G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Drowsiness G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Musculoskeletal and connective tissue disorders
Left ankle weakness G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Endocrine disorders
Hypothyroidism G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis G2
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Dehydration G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Retching G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Vascular disorders
Hypotension G3
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Lightheadedness G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
General disorders
Dizziness G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
|
Gastrointestinal disorders
Bloating G1
|
4.0%
1/25 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Patients were asked about adverse events at every clinic visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place