Trial Outcomes & Findings for Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma (NCT NCT04798781)
NCT ID: NCT04798781
Last Updated: 2025-12-11
Results Overview
Duration of time from start of treatment until progression or death, whichever comes first
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
through study completion, approximately 2.5 years
Results posted on
2025-12-11
Participant Flow
The trial opened to accrual on 7/12/2021 with first subject enrolled on study 7/28/2021. A total of 23 patients consented; 5 subjects failed screening; 2 were withdrawn; 16 subjects went on treatment, 1 subject (subject 009) withdrew consent; 15 completed study intervention evaluable. The study was closed to accrual on 02/07/2023 due to discontinuation of support by the drug supplier and funding source, due to postulated limited potential utility of the study drug.
Participant milestones
| Measure |
telatinib + Keytruda
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
Single Arm with 2 Cohorts:
Cohort 1: Gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy.
Cohort 2: Hepatocellular carcinoma, with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
telatinib + Keytruda
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
Single Arm with 2 Cohorts:
Cohort 1: Gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy.
Cohort 2: Hepatocellular carcinoma, with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Telatinib + Keytruda
n=15 Participants
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
Single Arm with 2 Cohorts:
Cohort 1: Gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy.
Cohort 2: Hepatocellular carcinoma, with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=237 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=237 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=237 Participants
|
|
Age, Continuous
|
66.93 years
STANDARD_DEVIATION 14.01 • n=237 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=237 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=237 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=237 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=237 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=237 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
|
Region of Enrollment
United States
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15 participants
n=237 Participants
|
PRIMARY outcome
Timeframe: through study completion, approximately 2.5 yearsDuration of time from start of treatment until progression or death, whichever comes first
Outcome measures
| Measure |
telatinib + Keytruda
n=15 Participants
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
|
|---|---|
|
Progression-free Survival
|
153.87 Days
Standard Deviation 133.69
|
SECONDARY outcome
Timeframe: from the start of treatment until the end of treatment, approximately 12 monthsThe percentage of patients who have a partial or complete response to treatment
Outcome measures
| Measure |
telatinib + Keytruda
n=15 Participants
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
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|---|---|
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Overall Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: from the start of treatment until the end of treatment, approximately 12 monthsThe percentage of patients who have stable disease, partial response, or complete response to treatment
Outcome measures
| Measure |
telatinib + Keytruda
n=15 Participants
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
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|---|---|
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Disease Control Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: from the start of treatment until time-of-eventThe length of time from the start of treatment that patients are still alive
Outcome measures
| Measure |
telatinib + Keytruda
n=15 Participants
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
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|---|---|
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Overall Survival
|
258 days
Interval 116.0 to 1238.0
|
SECONDARY outcome
Timeframe: from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 monthsIncidence and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5
Outcome measures
| Measure |
telatinib + Keytruda
n=313 Adverse Events (AEs)
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
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|---|---|
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Number and Severity of Adverse Events
Grade 1
|
161 Adverse Events (AEs)
|
|
Number and Severity of Adverse Events
Grade 2
|
87 Adverse Events (AEs)
|
|
Number and Severity of Adverse Events
Grade 3
|
57 Adverse Events (AEs)
|
|
Number and Severity of Adverse Events
Grade 4
|
7 Adverse Events (AEs)
|
|
Number and Severity of Adverse Events
Grade 5
|
1 Adverse Events (AEs)
|
Adverse Events
telatinib + Keytruda
Serious events: 8 serious events
Other events: 16 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
telatinib + Keytruda
n=16 participants at risk
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Biliary tract infection
|
6.2%
1/16 • Number of events 4 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Blood Bilirubin Increased
|
6.2%
1/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Injury, poisoning and procedural complications
Fracture
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Hepatobiliary disorders
Hepatic Failure
|
18.8%
3/16 • Number of events 7 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Lung Infection
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Metabolism and nutrition disorders
Other
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
Other adverse events
| Measure |
telatinib + Keytruda
n=16 participants at risk
Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 5 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Alanine Aminotransferase
|
31.2%
5/16 • Number of events 16 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Alkaline Phosphatase Increased
|
6.2%
1/16 • Number of events 5 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Anal Fistula
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Blood and lymphatic system disorders
Anemia
|
31.2%
5/16 • Number of events 17 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16 • Number of events 4 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 4 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Ascites
|
18.8%
3/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Asparate Aminotransferase Increased
|
31.2%
5/16 • Number of events 17 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Blood Bilirubin Increased
|
25.0%
4/16 • Number of events 10 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Cardiac disorders
Chest Pain- Cardiac
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Creatinine Increased
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
6/16 • Number of events 10 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Dry Mouth
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Renal and urinary disorders
Dyspnea
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Edema Face
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Edema Limbs
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Nervous system disorders
Encephalopathy
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Eye disorders
Eye Disorders- Other, Specify
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Eye disorders
Eye Pain
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Facial Pain
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Fatigue
|
62.5%
10/16 • Number of events 19 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Gait Disturbance
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
2/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
General Disorders and Administration Site Conditions - Other, Specify
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
General Disorders and Administration Site Conditions - Other, Specify
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Generalized Edema
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
18.8%
3/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Reproductive system and breast disorders
Genital Edema
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Hepatobiliary disorders
Hepatic Failure
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Vascular disorders
Hypertension
|
18.8%
3/16 • Number of events 20 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
General disorders
Localized Edema
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Mucositis Oral
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other, specify
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
3/16 • Number of events 6 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Nausea
|
56.2%
9/16 • Number of events 10 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Nausea
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Neutrophil Count Decreased
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Other
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Eye disorders
Other
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Other
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rash
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Reproductive system and breast disorders
Pelvic Pain
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Eye disorders
Periorbital Edema
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Investigations
Platelet Count Decreased
|
25.0%
4/16 • Number of events 8 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
12.5%
2/16 • Number of events 5 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Rectal Fissure
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Rectal Pain
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other, specify
|
6.2%
1/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Skin Infection
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Stomach Pain
|
12.5%
2/16 • Number of events 3 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Thrush
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Renal and urinary disorders
Urinary Frequency
|
12.5%
2/16 • Number of events 2 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Urinary Tract Infection
|
18.8%
3/16 • Number of events 5 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Renal and urinary disorders
Urinary Tract Infection
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Infections and infestations
Vaginal Infection
|
6.2%
1/16 • Number of events 1 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
6/16 • Number of events 8 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
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Investigations
Weight Loss
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31.2%
5/16 • Number of events 7 • approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place