Trial Outcomes & Findings for Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer (NCT NCT00923130)
NCT ID: NCT00923130
Last Updated: 2018-04-17
Results Overview
The time between the first day of treatment to the day of disease progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the longest diameter (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
30 participants
Primary outcome timeframe
up to 44 months
Results posted on
2018-04-17
Participant Flow
Participant milestones
| Measure |
Bevacizumab With Ixabepilone
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Bevacizumab With Ixabepilone
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Overall Study
Stopped treatment due to progression
|
17
|
|
Overall Study
Death
|
1
|
|
Overall Study
Discontinued treatment due to toxicities
|
3
|
|
Overall Study
Switched to alternative treatment
|
2
|
|
Overall Study
Refused further treatment
|
2
|
Baseline Characteristics
Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab With Ixabepilone
n=30 Participants
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Age, Continuous
|
61.17 years
STANDARD_DEVIATION 9.08 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=93 Participants
|
|
Prior Therapies
|
2 therapies
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 44 monthsThe time between the first day of treatment to the day of disease progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the longest diameter (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 |
Bevacizumab With Ixabepilone
n=30 Participants
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Progression-free Survival
|
8.3 months
Interval 4.9 to 10.6
|
SECONDARY outcome
Timeframe: Two YearsResponse (complete response (CR) and partial response (PR)) was measured by the RECIST. Complete response is the disappearance of all target lesions. 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.
Outcome measures
| Measure |
Bevacizumab With Ixabepilone
n=30 Participants
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Number of Participants With an Objective Response (Complete Response (CR) or Partial Response (PR)) Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
0 Participants
|
|
Number of Participants With an Objective Response (Complete Response (CR) or Partial Response (PR)) Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
3 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 84 months and 25 daysHere is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. Adverse events are assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Bevacizumab With Ixabepilone
n=30 Participants
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Number of Participants With Adverse Events
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1Population: This outcome measure was not done because biopsy samples were not obtained.
To obtain tumor tissue and perform analysis for molecular changes in the tumor before and after a cycle of chemotherapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time between the first day of treatment and the day of death, assessed up to approximately 7 years.Time between the first day of treatment and the day of death.
Outcome measures
| Measure |
Bevacizumab With Ixabepilone
n=30 Participants
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Overall Survival
|
15.0 months
Interval 11.3 to 29.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 Day 5 (C1D5), Cycle 2 Day 1 (C2D1), Cycle 4 and Cycle 6Population: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 5, and Cycle 2 Day 1Population: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to cycle 2Population: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 Day 5, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 6 Day 1Population: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 50 daysPopulation: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 before day 1 of treatment and day 5 following infusionPopulation: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 before day 1 of treatment and day 5 following infusionPopulation: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 50 daysPopulation: This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.
This assessment was intended as an exploratory analysis.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab With Ixabepilone
Serious events: 9 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab With Ixabepilone
n=30 participants at risk
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Cardiac arrest
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Enterocolitis infectious
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Kidney infection
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Presyncope
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Urinary tract obstruction
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Proteinuria
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Stroke
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
Other adverse events
| Measure |
Bevacizumab With Ixabepilone
n=30 participants at risk
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
5/30 • Number of events 7 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
53.3%
16/30 • Number of events 37 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
6/30 • Number of events 13 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Alkaline phosphatase increased
|
26.7%
8/30 • Number of events 20 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Immune system disorders
Allergic reaction
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
26.7%
8/30 • Number of events 13 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
12/30 • Number of events 13 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.3%
1/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
20/30 • Number of events 180 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Anorexia
|
43.3%
13/30 • Number of events 26 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
8/30 • Number of events 14 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
9/30 • Number of events 31 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
4/30 • Number of events 7 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, bleeding gums and DVT
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Blood bilirubin increased
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Eye disorders
Blurred vision
|
10.0%
3/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Bronchial infection
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
6.7%
2/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Injury, poisoning and procedural complications
Bruising
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
CPK increased
|
13.3%
4/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Catheter related infection
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Cheilitis
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Chills
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Cognitive disturbance
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Conduction disorder
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Constipation
|
36.7%
11/30 • Number of events 13 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
10/30 • Number of events 22 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Creatinine increased
|
60.0%
18/30 • Number of events 140 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Diarrhea
|
53.3%
16/30 • Number of events 35 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Dizziness
|
16.7%
5/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Eye disorders
Dry eye
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Dysesthesia
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Dysgeusia
|
23.3%
7/30 • Number of events 7 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Edema face
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Edema limbs
|
30.0%
9/30 • Number of events 15 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Enterocolitis
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Enterocolitis infectious
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.7%
8/30 • Number of events 12 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Esophageal infection
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Ear and labyrinth disorders
External ear pain
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 68 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Fever
|
16.7%
5/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Flu like symptoms
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Injury, poisoning and procedural complications
Fracture
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Gait disturbance
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, excessive saliva
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Hematuria
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Vascular disorders
Hot flashes
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
30.0%
9/30 • Number of events 26 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
3/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
46.7%
14/30 • Number of events 52 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
13.3%
4/30 • Number of events 7 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
13.3%
4/30 • Number of events 9 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Vascular disorders
Hypertension
|
53.3%
16/30 • Number of events 479 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
13.3%
4/30 • Number of events 7 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
20/30 • Number of events 191 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
4/30 • Number of events 18 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
2/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
4/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
36.7%
11/30 • Number of events 32 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
15/30 • Number of events 48 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
43.3%
13/30 • Number of events 26 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Vascular disorders
Hypotension
|
10.0%
3/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Infections and infestations - Other, lung
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Investigations - Other, bicarbonate low
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Laryngitis
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Lung infection
|
13.3%
4/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Lymphocyte count decreased
|
56.7%
17/30 • Number of events 206 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Lymphocyte count increased
|
6.7%
2/30 • Number of events 6 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Malaise
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Movements involuntary
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Mucosal infection
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
5/30 • Number of events 12 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
5/30 • Number of events 8 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Nail infection
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
40.0%
12/30 • Number of events 17 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
15/30 • Number of events 42 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, basal cell
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Nervous system disorders - Other, cold intolerance
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Neutrophil count decreased
|
43.3%
13/30 • Number of events 26 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Olfactory nerve disorder
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
General disorders
Pain
|
10.0%
3/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.7%
8/30 • Number of events 8 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
60.0%
18/30 • Number of events 33 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Platelet count decreased
|
26.7%
8/30 • Number of events 40 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
5/30 • Number of events 5 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Presyncope
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
5/30 • Number of events 17 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
3/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
2/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Rhinitis infective
|
6.7%
2/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Serum amylase increased
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
2/30 • Number of events 16 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
3/30 • Number of events 8 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
3/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Skin infection
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.3%
1/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Somnolence
|
6.7%
2/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, knee replacement
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Nervous system disorders
Syncope
|
10.0%
3/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Vascular disorders
Thromboembolic event
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
6/30 • Number of events 8 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • Number of events 3 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Renal and urinary disorders
Urinary tract pain
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Infections and infestations
Vaginal infection
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30 • Number of events 14 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Eye disorders
Watering eyes
|
3.3%
1/30 • Number of events 1 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
Weight loss
|
13.3%
4/30 • Number of events 4 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
2/30 • Number of events 2 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
|
Investigations
White blood cell decreased
|
50.0%
15/30 • Number of events 90 • 8Date treatment consent signed to date off study, approximately 4 months and 25 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place