Trial Outcomes & Findings for A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy (NCT NCT02053376)
NCT ID: NCT02053376
Last Updated: 2019-01-30
Results Overview
Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Regorafenib
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy
Baseline characteristics by cohort
| Measure |
Regorafenib
n=43 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Age, Continuous
|
62.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received at least one dose of regorafenib.
Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Regorafenib
n=43 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Progression-free Survival (PFS)
|
3.58 months
Interval 2.96 to 5.68
|
PRIMARY outcome
Timeframe: up to 4 yearsPopulation: Patients who received two or more doses of regorafenib.
Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Regorafenib
n=31 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Progression-free Survival (PFS) - Two or More Doses
|
3.91 months
Interval 3.55 to 7.39
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received at least one dose of regorafenib and were evaluable for response
The number of patients who experienced a Partial Response (PR) + the number of patients who experienced a Complete Response (CR) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Regorafenib
n=34 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Proportion of Participants With Overall Response (OR)
|
0.147 proportion of participants
Interval 0.06 to 0.285
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received at least one dose of regorafenib.
The length of time from the start of study treatment that patients remained alive.
Outcome measures
| Measure |
Regorafenib
n=43 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Overall Survival (OS)
|
5.55 months
Interval 4.43 to 13.4
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received two or more doses of regorafenib.
The length of time from the start of study treatment that patients remained alive.
Outcome measures
| Measure |
Regorafenib
n=31 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Overall Survival (OS) - Two or More Doses
|
9.43 months
Interval 5.72 to 19.4
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received at least one dose of regorafenib and were evaluable for response
Number of patients who achieved Complete Response (CR) + number of patients who achieved Partial Response (PR) + number of patients who achieved Stable Disease (SD) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study treatment.
Outcome measures
| Measure |
Regorafenib
n=34 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Disease Control Rate (DCR)
|
0.706 proportion of participants
Interval 0.552 to 0.831
|
SECONDARY outcome
Timeframe: At baseline prior to treatment and after all treatment received, up to 4 yearsPopulation: Patients who received at least one dose of regorafenib and for which CA19-9 levels were obtainable.
The difference between the levels of Cancer antigen 19-9 (CA19-9) prior to treatment compared to after treatment.
Outcome measures
| Measure |
Regorafenib
n=40 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Changes in Cancer Antigen 19-9 (CA19-9) Level
Before Treatment
|
100.6 mg/dL
Interval 6.9 to 20558.0
|
|
Changes in Cancer Antigen 19-9 (CA19-9) Level
After Treatment
|
186.6 mg/dL
Interval 8.0 to 28842.0
|
SECONDARY outcome
Timeframe: At baseline prior to treatment and after all treatment received, up to 4 years.Population: Patients who received at least one dose of regorafenib.
The difference between the levels of Carcinoembryonic antigen (CEA) prior to treatment compared to after treatment. ng/ml
Outcome measures
| Measure |
Regorafenib
n=35 Participants
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Change in Carcinoembryonic Antigen (CEA)
|
3.88 ng/ml
Interval 1.11 to 6.9
|
Adverse Events
Regorafenib
Serious events: 27 serious events
Other events: 43 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Regorafenib
n=43 participants at risk
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Cardiac disorders
Cardiac arrest
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Fever
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Multi-organ failure
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Pain
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Infections and infestations
Biliary tract infection
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Infections and infestations
Device related infection
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Infections and infestations
Lung infection
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Infections and infestations
Wound infection
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Blood bilirubin increased
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Platelet count decreased
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Psychiatric disorders
Confusion
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Renal and urinary disorders
Hematuria
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Renal and urinary disorders
Renal calculi
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Vascular disorders
Hypertension
|
4.7%
2/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
Other adverse events
| Measure |
Regorafenib
n=43 participants at risk
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with regorafenib (120 mg) (160 mg for second and subsequent treatment cycles) orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle
regorafenib: (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
76.7%
33/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Cardiac disorders
Sinus bradycardia
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Cardiac disorders
Sinus tachycardia
|
27.9%
12/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Flatulence
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Ascites
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Constipation
|
16.3%
7/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Vomiting
|
25.6%
11/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Diarrhea
|
30.2%
13/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Nausea
|
30.2%
13/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.2%
16/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Chills
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Edema limbs
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Fever
|
18.6%
8/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Pain
|
30.2%
13/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
39.5%
17/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
General disorders
Fatigue
|
72.1%
31/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Lymphocyte count increased
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
INR increased
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Investigations - Other, specify
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Lipase increased
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Weight loss
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Neutrophil count decreased
|
25.6%
11/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Creatinine increased
|
27.9%
12/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Lymphocyte count decreased
|
44.2%
19/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
White blood cell decreased
|
44.2%
19/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Blood bilirubin increased
|
55.8%
24/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Alanine aminotransferase increased
|
58.1%
25/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Alkaline phosphatase increased
|
67.4%
29/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Platelet count decreased
|
67.4%
29/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Investigations
Aspartate aminotransferase increased
|
76.7%
33/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.3%
7/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
18.6%
8/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.3%
10/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.9%
12/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
27.9%
12/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
34.9%
15/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.9%
18/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
65.1%
28/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
76.7%
33/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
76.7%
33/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Nervous system disorders
Dizziness
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Nervous system disorders
Headache
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Renal and urinary disorders
Urine discoloration
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Renal and urinary disorders
Hematuria
|
9.3%
4/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
23.3%
10/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
3/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.6%
5/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
20.9%
9/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.6%
11/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Vascular disorders
Hypotension
|
14.0%
6/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
|
Vascular disorders
Hypertension
|
51.2%
22/43 • Adverse event(s) data were collected over an approximately 4 year period of time.
|
Additional Information
Barbara Stadterman, Regulatory Supervisor
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place