Trial Outcomes & Findings for Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers (NCT NCT02829918)
NCT ID: NCT02829918
Last Updated: 2025-12-22
Results Overview
Response in participants with advanced biliary tract cancers receiving nivolumab as a single agent. ORR is defined as complete responses (CR) plus partial responses (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-12-22
Participant Flow
Participants were recruited at Moffitt Cancer Center, City of Hope Cancer Center and Winship Cancer Center October 2016 through January 2019.
Participant milestones
| Measure |
Nivolumab Treatment
This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.
Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg every 4 weeks (Q4W) from 17 weeks to end of study.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Nivolumab Treatment
This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.
Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg every 4 weeks (Q4W) from 17 weeks to end of study.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Progression
|
1
|
Baseline Characteristics
Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers
Baseline characteristics by cohort
| Measure |
Nivolumab Treatment
n=54 Participants
This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.
Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg Q4W from 17 weeks to end of study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: 46 participants were evaluable for response
Response in participants with advanced biliary tract cancers receiving nivolumab as a single agent. ORR is defined as complete responses (CR) plus partial responses (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Outcome measures
| Measure |
Nivolumab Treatment
n=46 Participants
This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.
Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg Q4W from 17 weeks to end of study.
|
|---|---|
|
Overall Response Rate (ORR) After 4 Cycles of Treatment
|
22 percent
|
SECONDARY outcome
Timeframe: Up to 36 monthsOS is defined as the time from enrollment to the date of death.
Outcome measures
| Measure |
Nivolumab Treatment
n=46 Participants
This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.
Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg Q4W from 17 weeks to end of study.
|
|---|---|
|
Overall Survival (OS)
|
8.9 months
Interval 5.2 to 17.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: 46 participants evaluable
PFS is defined as the time from first treatment to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.
Outcome measures
| Measure |
Nivolumab Treatment
n=46 Participants
This is a single arm study with two stage design using nivolumab in advanced biliary tract cancer (BTC), for participants who have failed or are intolerant to at least one line of therapy and no more than 2 lines of therapy. In the first stage, 18 participants will be accrued. If there is at least one response (or several participants with stable disease based on the study team's discretion), an additional 34 patients will be accrued for a total of 52 patients.
Nivolumab: Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 mg Q4W from 17 weeks to end of study.
|
|---|---|
|
Progression Free Survival (PFS)
|
3.68 months
Interval 2.3 to 5.69
|
Adverse Events
Nivolumab Treatment
Serious events: 32 serious events
Other events: 52 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nivolumab Treatment
n=54 participants at risk
All participants receiving at least one dose of Nivolumab per protocol.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Death NOS
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Fever
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Immune system disorders
Allergic reaction
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Infections and infestations - Other
|
3.7%
2/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Lung infection
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Sepsis
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Alkaline phosphatase increased
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Blood bilirubin increased
|
11.1%
6/54 • Number of events 6 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Stroke
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Vascular disorders
Hypotension
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
Other adverse events
| Measure |
Nivolumab Treatment
n=54 participants at risk
All participants receiving at least one dose of Nivolumab per protocol.
|
|---|---|
|
General disorders
Infusion related reaction
|
7.4%
4/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
10/54 • Number of events 12 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Weight loss
|
33.3%
18/54 • Number of events 24 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.5%
10/54 • Number of events 13 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Blood and lymphatic system disorders
Anemia
|
18.5%
10/54 • Number of events 13 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
46.3%
25/54 • Number of events 35 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Edema limbs
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Fatigue
|
38.9%
21/54 • Number of events 24 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
9/54 • Number of events 13 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
6/54 • Number of events 6 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
9/54 • Number of events 14 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Headache
|
7.4%
4/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
9.3%
5/54 • Number of events 7 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Psychiatric disorders
Depression
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
12/54 • Number of events 14 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Fever
|
16.7%
9/54 • Number of events 14 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.8%
8/54 • Number of events 16 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
3/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders -Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Chills
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Infections and infestations - Other
|
3.7%
2/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Skin infection
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Cardiac disorders
Palpitations
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Cardiac disorders
Ventricular arrhthmia
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Creatinine increased
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Platelet count decreased
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Ascites
|
7.4%
4/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
9/54 • Number of events 14 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Sepsis
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Urinary Tract Infection
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Blood bilirubin increased
|
13.0%
7/54 • Number of events 12 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.4%
4/54 • Number of events 9 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.4%
4/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Endocrine disorders
Hyperthyroidism
|
3.7%
2/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Eye disorders
Eye disorders - Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
14.8%
8/54 • Number of events 9 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Nausea
|
18.5%
10/54 • Number of events 15 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
13/54 • Number of events 20 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
White blood cell decreased
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
2/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
9/54 • Number of events 9 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Vascular disorders
Hypertension
|
14.8%
8/54 • Number of events 20 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
2/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Dry mouth
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Abdominal infection
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Dizziness
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Psychiatric disorders
Insomnia
|
7.4%
4/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.3%
5/54 • Number of events 6 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Vascular disorders
Hypotension
|
11.1%
6/54 • Number of events 7 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Urinary frequency
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.4%
4/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.7%
2/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.4%
4/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Psychiatric disorders
Anxiety
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.9%
1/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Investigations -Other
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
5/54 • Number of events 9 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
12/54 • Number of events 14 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Hematuria
|
3.7%
2/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
4/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Immune system disorders
Allergic reaction
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hypoalbumenemia
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Colitis
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Endocrine disorders
Endocrine disorders - Other
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Vaginal infection
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
3/54 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
9.3%
5/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
General disorders and administration site conditions - Other
|
7.4%
4/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Renal and urinary disorders
Urine discoloration
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Vascular disorders
Thromboembolic event
|
3.7%
2/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Eye disorders
Blurred vision
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.4%
4/54 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
3/54 • Number of events 3 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Gastrointestinal disorders
Bloating
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Flu like symptoms
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Malaise
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
INR increased
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Weight gain
|
13.0%
7/54 • Number of events 10 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
General disorders
Edema face
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Nervous system disorders - Other
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Nervous system disorders
Lethargy
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Blood and lymphatic system disorders
Spleen disorder
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Tooth infection
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Papulopustular rash
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Cardiac disorders
Sinus bradycardia
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
2/54 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Eye disorders
Cataract
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Vascular disorders
Flushing
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
|
Infections and infestations
Bronchial infection
|
1.9%
1/54 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 30 days from end of treatment. All Serious Adverse Events collected from on treatment date to within 100 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 28 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place