Trial Outcomes & Findings for Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy (NCT NCT02300545)
NCT ID: NCT02300545
Last Updated: 2020-08-05
Results Overview
Clinical benefit rate = complete response (CR) + partial response (PR) + stable disease (SD) * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-08-05
Participant Flow
The study opened to participant enrollment on 04/08/2015 and closed to participant enrollment on 02/20/2019.
Participant milestones
| Measure |
Pazopanib
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy
Baseline characteristics by cohort
| Measure |
Pazopanib
n=56 Participants
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
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|---|---|
|
Age, Continuous
|
78.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksClinical benefit rate = complete response (CR) + partial response (PR) + stable disease (SD) * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Pazopanib
n=56 Participants
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
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|---|---|
|
Clinical Benefit Rate
|
22 Participants
|
SECONDARY outcome
Timeframe: Until disease progression (median follow-up of 10.83 months with full range 0.787-42.26 months)PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Pazopanib
n=56 Participants
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
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|---|---|
|
Progression-free Survival (PFS)
|
3.67 months
Interval 2.62 to 7.25
|
SECONDARY outcome
Timeframe: Until death (median follow-up of 10.83 months with full range 0.787-42.26 months)Outcome measures
| Measure |
Pazopanib
n=56 Participants
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
|
|---|---|
|
Overall Survival (OS)
|
14.16 months
Interval 8.46 to
The upper 95% confidence interval was not reached.
|
SECONDARY outcome
Timeframe: Change from baseline to end of treatment (median length of treatment 70 days (5-515 days)))* Quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G7) validated survey * 7 statements where the participant can indicate 0 (not at all) up to 4 (very much). The statements include 1) I have lack of energy; 2) I have pain; 3) I have nausea; 4) I worry that my condition will get worse; 5) I am sleeping well; 6) I am able to enjoy life; 7) I am content with the quality of my life right now. * The first 4 statements will negatively affect the total score and the last 3 statements will positively affect the total score * Each item is scored and then added together, multiplied by 7, and divided by the number of items * Total score calculation ranges from 0-28. The higher the score, the better the quality of life
Outcome measures
| Measure |
Pazopanib
n=56 Participants
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
|
|---|---|
|
Median Overall Change in Quality of Life
|
2 points on a scale
Interval 0.7356979 to 4.583451
|
SECONDARY outcome
Timeframe: From baseline through completion of treatmentPopulation: There was no funding to process the serum levels of sVEGFR2.
The serum levels of sVEGFR2 at each time point will plotted and Pearson or Spearman's correlation coefficient will be calculated to explore their relationship.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline through completion of treatmentPopulation: There was no funding to process the serum levels of PIGF.
The serum levels of PIGF at each time point will plotted and Pearson or Spearman's correlation coefficient will be calculated to explore their relationship.
Outcome measures
Outcome data not reported
Adverse Events
Pazopanib
Serious events: 27 serious events
Other events: 56 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Pazopanib
n=56 participants at risk
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Atrial flutter
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Heart failure
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Bowel infarction related to disease
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Colonic fistula
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
GI bleed
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Jejunal perforation
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
General disorders
Fatigue
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Infections and infestations
Bronchial infection
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Infections and infestations
Colitis
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Infections and infestations
Lung infection
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Neutrophil count decreased
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
7.1%
4/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Transient ischemic attacks
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Psychiatric disorders
Agitation
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Hypertension
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Intratumoral hemorrhage
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Thromboembolic event
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
Other adverse events
| Measure |
Pazopanib
n=56 participants at risk
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
32.1%
18/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Heart failure
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Cardiac disorders
Palpitations
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
4/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Eye disorders
Blurred vision
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Eye disorders
Vision changes
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
10/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Belching
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Bloating
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Constipation
|
17.9%
10/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
51.8%
29/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
4/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
8/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Nausea
|
48.2%
27/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
33.9%
19/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
General disorders
Chills
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Gastrointestinal disorders
Edema face
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
General disorders
Edema limbs
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
General disorders
Fatigue
|
58.9%
33/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
General disorders
Hair depigmentation
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
23.2%
13/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
8.9%
5/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
21/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Blood bilirubin increased
|
19.6%
11/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Creatinine increased
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Ejection fraction decreased
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
GGT increased
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Lipase increased
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Lymphocyte count decreased
|
10.7%
6/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Neutrophil count decreased
|
8.9%
5/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Platelet count decreased
|
30.4%
17/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
Weight loss
|
14.3%
8/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Investigations
White blood cell decreased
|
25.0%
14/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.1%
18/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
4/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.9%
5/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
4/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.7%
6/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.7%
6/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Concentration impairment
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Dizziness
|
10.7%
6/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Dysgeusia
|
23.2%
13/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Headache
|
14.3%
8/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Lethargy
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Memory impairment
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Paresthesia
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Presyncope
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Nervous system disorders
Right hand paralysis
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Psychiatric disorders
Confusion
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Psychiatric disorders
Depression
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Psychiatric disorders
Insomnia
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Renal and urinary disorders
Hematuria
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Reproductive system and breast disorders
Night sweats
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.4%
3/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.9%
5/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Hot flashes
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Hypertension
|
41.1%
23/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
|
Vascular disorders
Thromboembolic event
|
3.6%
2/56 • -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.
The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.
|
Additional Information
Brian A. Van Tine, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-747-8475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place