Trial Outcomes & Findings for BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer (NCT NCT00326495)
NCT ID: NCT00326495
Last Updated: 2017-07-24
Results Overview
Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
4 months
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
BAY 43-9006 & Cetuximab
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
BAY 43-9006 & Cetuximab
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Overall Study
Switched to alternative treatment
|
1
|
|
Overall Study
Disease progression before treatment
|
1
|
|
Overall Study
Refused further treatment
|
2
|
|
Overall Study
Subject off study before assessment
|
1
|
Baseline Characteristics
BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer
Baseline characteristics by cohort
| Measure |
BAY 43-9006 & Cetuximab
n=51 Participants
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
53.65 years
STANDARD_DEVIATION 13.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
|
Median Number of Previous Treatments
|
3 Treatments
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Although 51 patients were accrued, only 50 were on study long enough for assessment.
Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
BAY 43-9006 & Cetuximab
n=50 Participants
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Overall Rate of Response
|
15 percentage of participants
|
SECONDARY outcome
Timeframe: 96 months, 26 daysPopulation: Although 51 patients were accrued, only 50 were on study long enough for assessment.
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
BAY 43-9006 & Cetuximab
n=50 Participants
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Count of Participants With Adverse Events
|
50 Participants
|
Adverse Events
BAY 43-9006 & Cetuximab
Serious events: 22 serious events
Other events: 50 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
BAY 43-9006 & Cetuximab
n=50 participants at risk
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Immune system disorders
Anaphylaxis
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Bladder infection
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Chills
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Death NOS
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Dehydration
|
2.0%
1/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Fever
|
10.0%
5/50 • Number of events 5 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/50 • Number of events 5 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Lipase increased
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Movements involuntary
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.0%
6/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Tooth infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Wound infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
Other adverse events
| Measure |
BAY 43-9006 & Cetuximab
n=50 participants at risk
BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m\^2 initially as a loading dose on week 2, followed by 250 mg/m\^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
3/50 • Number of events 4 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.0%
14/50 • Number of events 22 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
34.0%
17/50 • Number of events 36 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Alanine aminotransferase increased
|
66.0%
33/50 • Number of events 82 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Alkaline phosphatase increased
|
62.0%
31/50 • Number of events 60 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.0%
3/50 • Number of events 4 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.0%
1/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Anal pain
|
2.0%
1/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
25/50 • Number of events 62 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.0%
13/50 • Number of events 19 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
4/50 • Number of events 5 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Ascites
|
12.0%
6/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
70.0%
35/50 • Number of events 92 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Ataxia
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.0%
4/50 • Number of events 4 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Bloating
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Blood bilirubin increased
|
42.0%
21/50 • Number of events 51 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Eye disorders
Blurred vision
|
4.0%
2/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
5/50 • Number of events 8 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Injury, poisoning and procedural complications
Burn
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
CPK increased
|
14.0%
7/50 • Number of events 13 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Cheilitis
|
6.0%
3/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Chills
|
18.0%
9/50 • Number of events 14 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Psychiatric disorders
Confusion
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
10/50 • Number of events 17 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
7/50 • Number of events 7 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Creatinine increased
|
12.0%
6/50 • Number of events 12 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Immune system disorders
Cytokine release syndrome
|
14.0%
7/50 • Number of events 8 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
10/50 • Number of events 15 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
64.0%
32/50 • Number of events 152 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Number of events 7 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
12.0%
6/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
38.0%
19/50 • Number of events 19 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Dysgeusia
|
14.0%
7/50 • Number of events 7 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
5/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
4/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Edema face
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Edema limbs
|
4.0%
2/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
4/50 • Number of events 7 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Fatigue
|
50.0%
25/50 • Number of events 34 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Fever
|
36.0%
18/50 • Number of events 36 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Flatulence
|
14.0%
7/50 • Number of events 10 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Flu like symptoms
|
6.0%
3/50 • Number of events 4 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Headache
|
44.0%
22/50 • Number of events 29 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Hematuria
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Hemoglobinuria
|
6.0%
3/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.0%
2/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.0%
3/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
18.0%
9/50 • Number of events 14 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
5/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.0%
3/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
5/50 • Number of events 9 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
16.0%
8/50 • Number of events 12 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.0%
4/50 • Number of events 5 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Vascular disorders
Hypertension
|
32.0%
16/50 • Number of events 100 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.0%
4/50 • Number of events 8 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
84.0%
42/50 • Number of events 127 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
10/50 • Number of events 14 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
34.0%
17/50 • Number of events 40 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
52.0%
26/50 • Number of events 58 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
30/50 • Number of events 73 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
68.0%
34/50 • Number of events 117 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Infections and infestations - Other,Upper airway NOS
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Infusion related reaction
|
6.0%
3/50 • Number of events 6 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Psychiatric disorders
Insomnia
|
6.0%
3/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Investigations - Other, specify
|
12.0%
6/50 • Number of events 12 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Lip infection
|
2.0%
1/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Lipase increased
|
4.0%
2/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Lymphocyte count decreased
|
66.0%
33/50 • Number of events 115 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Mucosal infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Mucositis oral
|
26.0%
13/50 • Number of events 22 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Restless leg
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.0%
11/50 • Number of events 12 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.0%
1/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Nausea
|
42.0%
21/50 • Number of events 51 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Neutrophil count decreased
|
10.0%
5/50 • Number of events 17 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
General disorders
Pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
4/50 • Number of events 5 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
38.0%
19/50 • Number of events 30 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
2/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Platelet count decreased
|
42.0%
21/50 • Number of events 44 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
5/50 • Number of events 10 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
38.0%
19/50 • Number of events 26 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
70.0%
35/50 • Number of events 68 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
20/50 • Number of events 43 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Rectal pain
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Reproductive system and breast disorders
Scrotal pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Serum amylase increased
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
4/50 • Number of events 12 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Skin infection
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
8.0%
4/50 • Number of events 5 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Tooth infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Urinary frequency
|
6.0%
3/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Urinary tract infection
|
14.0%
7/50 • Number of events 9 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Renal and urinary disorders
Urine discoloration
|
4.0%
2/50 • Number of events 2 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Vascular disorders
Vascular disorders - Other, Ecchymosis
|
2.0%
1/50 • Number of events 1 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Number of events 3 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
18.0%
9/50 • Number of events 9 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
20/50 • Number of events 42 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
Weight loss
|
26.0%
13/50 • Number of events 13 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
|
Investigations
White blood cell decreased
|
32.0%
16/50 • Number of events 49 • 96 months, 26 days
Although 51 patients were accrued, only 50 were on study long enough for assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place