Trial Outcomes & Findings for Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma (NCT NCT00447330)
NCT ID: NCT00447330
Last Updated: 2015-02-13
Results Overview
Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
5 years from study start date
Results posted on
2015-02-13
Participant Flow
81 subjects consented, 21 were screen failures, 60 subjects were considered enrolled.
Participant milestones
| Measure |
1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma
Baseline characteristics by cohort
| Measure |
1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
n=60 Participants
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 years from study start datePopulation: All patients with at least one scheduled restaging who received treatment. However, an additional 3 patients who progressed before treatment are not included in this analysis.
Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.
Outcome measures
| Measure |
1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
n=49 Participants
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Median Progression-Free Survival (PFS)
|
6.97 survival time in months
Interval 6.41 to 8.15
|
SECONDARY outcome
Timeframe: Every 21 daysNumber of subjects who experienced an adverse event
Outcome measures
| Measure |
1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
n=58 Participants
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma
|
56 participants
|
SECONDARY outcome
Timeframe: Every 9 weeks for up to 1 yearPopulation: All eligible patients.
The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.
Outcome measures
| Measure |
1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
n=60 Participants
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Response Rate
|
41.7 percentage of participants
Interval 29.1 to 55.1
|
SECONDARY outcome
Timeframe: 5 years after study start datePopulation: All patients who received treatment are included in the analysis population. However, 2 patients who never started treatment before leaving the study were excluded from this analysis of survival time.
Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.
Outcome measures
| Measure |
1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin
n=58 Participants
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Median Survival
|
10.51 survival time in months
Interval 8.61 to 12.22
|
Adverse Events
1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
Serious events: 33 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
n=58 participants at risk
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Esophageal perforation
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Death NOS
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Fatigue
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Pain
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Lung infection
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Dysphasia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Syncope
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Vascular disorders
Thromboembolic event
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
Other adverse events
| Measure |
1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti
n=58 participants at risk
capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Eye disorders
Blurred vision
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
7/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Anal mucositis
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
31.0%
18/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
44.8%
26/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
8.6%
5/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Esophagitis
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
48.3%
28/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Stomach pain
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
39.7%
23/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Chills
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Edema limbs
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Facial pain
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Fatigue
|
48.3%
28/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Fever
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
General disorders
Pain
|
20.7%
12/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Immune system disorders
Allergic reaction
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Lung infection
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Nail infection
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Alkaline phosphatase increased
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
5/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
CPK increased
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Investigations - Other, specify
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
27.6%
16/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Platelet count decreased
|
17.2%
10/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
Weight loss
|
17.2%
10/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Investigations
White blood cell decreased
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
41.4%
24/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
15.5%
9/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
15.5%
9/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Dysphasia
|
5.2%
3/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Headache
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
8.6%
5/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
55.2%
32/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Syncope
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Nervous system disorders
Tremor
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Psychiatric disorders
Confusion
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Psychiatric disorders
Depression
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Psychiatric disorders
Personality change
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Renal and urinary disorders
Urinary frequency
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
9/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.8%
8/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
8.6%
5/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.1%
7/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
29.3%
17/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.3%
6/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.7%
1/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Vascular disorders
Hypertension
|
13.8%
8/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Vascular disorders
Hypotension
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Vascular disorders
Thromboembolic event
|
6.9%
4/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.4%
2/58 • Adverse event data were collected from first dose of study drug until 30 days after last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place