Trial Outcomes & Findings for Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (NCT NCT01853644)
NCT ID: NCT01853644
Last Updated: 2021-10-12
Results Overview
ORR is defined as the number of patients with complete response plus those with partial response as measured by RECIST 1.1 where: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)
Results posted on
2021-10-12
Participant Flow
The study opened to enrollment on May 23, 2013 with the first patient being enrolled and treated on the study on June 6, 2013. The study closed to further enrollment August 10, 2018 with 31 patients registered to the study and 30 patients treated on study.
Participant milestones
| Measure |
Treatment (Tivozanib)
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Registration and Treatment Start
STARTED
|
31
|
|
Registration and Treatment Start
Registered
|
31
|
|
Registration and Treatment Start
Started Treatment
|
30
|
|
Registration and Treatment Start
COMPLETED
|
30
|
|
Registration and Treatment Start
NOT COMPLETED
|
1
|
|
Reached First Response/Complete 2 Cycles
STARTED
|
30
|
|
Reached First Response/Complete 2 Cycles
COMPLETED
|
24
|
|
Reached First Response/Complete 2 Cycles
NOT COMPLETED
|
6
|
|
Continued Treatment After First Response
STARTED
|
24
|
|
Continued Treatment After First Response
COMPLETED
|
12
|
|
Continued Treatment After First Response
NOT COMPLETED
|
12
|
|
Follow up for 3 Years or Until Death
STARTED
|
30
|
|
Follow up for 3 Years or Until Death
COMPLETED
|
30
|
|
Follow up for 3 Years or Until Death
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Treatment (Tivozanib)
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Registration and Treatment Start
Did not start treatment
|
1
|
|
Reached First Response/Complete 2 Cycles
Adverse Event
|
2
|
|
Reached First Response/Complete 2 Cycles
Withdrawal by Subject
|
1
|
|
Reached First Response/Complete 2 Cycles
Other
|
1
|
|
Reached First Response/Complete 2 Cycles
Progressive Disease
|
2
|
|
Continued Treatment After First Response
Adverse Event
|
2
|
|
Continued Treatment After First Response
Progressive Diseaes
|
10
|
Baseline Characteristics
Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)Population: 6 patients who were determined to not be evaluable and are not included in the overall number of patients analyzed
ORR is defined as the number of patients with complete response plus those with partial response as measured by RECIST 1.1 where: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=24 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Overall Response Rate (ORR)
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsThe Kaplan-Meier method will be utilized to estimate the median and overall distribution of PFS and will be defined from the start of treatment until the first documentation of progressive disease or death, whichever occurs first..
Outcome measures
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Progression Free Survival (PFS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
|
4.06 months
Interval 1.74 to 5.78
|
SECONDARY outcome
Timeframe: During treatment and up to 30 days after completion of study treatment. Range of cycles 1-32 (1 cycle =28 days).Adverse events will be assessed by NCI CTCAE v 4.03. Adverse event that were determined to be serious adverse events (either grade 3, 4, or 5) related to study drug were collected. Grading is as follows:In general the following severity definitions are true: Mild (grade 1): the event causes discomfort without disruption of normal daily activities. Moderate (grade 2): the event causes discomfort that affects normal daily activities. Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Life-threatening (grade 4): the patient was at risk of death at the time of the event. Fatal (grade 5): the event caused death.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Hypertension
|
8 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Proteinuria
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Hypoalbuminemia
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Portal hypertension
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Fatigue
|
3 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Hyponatremia
|
2 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Colonic Fistula
|
2 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Nausea
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Hypomagnesemia
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Anemia
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Small intestinal perforation
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Stroke
|
1 Participants
|
|
Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Small intestinal obstruction
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsOS is defined from the start of treatment until date of death from any cause or date of last contact.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Overall Survival (OS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
|
8.64 months
Interval 5.39 to 12.5
|
POST_HOC outcome
Timeframe: Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)Overall Best Response as measured by physical exam findings, serum CA125 levels and/or measurement of index lesions via appropriate imaging studies using RECIST criteria defined as either: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Overall Best Response of Patients With Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
PD
|
6 Participants
|
|
Overall Best Response of Patients With Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
Not Evaluable
|
6 Participants
|
|
Overall Best Response of Patients With Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
SD
|
14 Participants
|
|
Overall Best Response of Patients With Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
CR
|
0 Participants
|
|
Overall Best Response of Patients With Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib
PR
|
4 Participants
|
POST_HOC outcome
Timeframe: Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)Population: 6 patients were determined to be not evaluable are not included in the overall number of patients analyzed
CBR is defined as the number of patients with Complete Response (CR) plus those with Partial Response (PR) plus those with Stable Disease (SD) as assessed by RECIST 1.1 where: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=24 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
18 participants
|
POST_HOC outcome
Timeframe: at 3, 6 and 12 months from start of treatmentPFS rate will be measured by the number of patients that are progression free at 3, 6 and 12 months from treatment initiation.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
3, 6, and 12 Month Progression Free Survival
3 months
|
0.567 probability of patients progression free
Interval 0.414 to 0.775
|
|
3, 6, and 12 Month Progression Free Survival
6 months
|
0.267 probability of patients progression free
Interval 0.147 to 0.483
|
|
3, 6, and 12 Month Progression Free Survival
12 months
|
0.067 probability of patients progression free
Interval 0.017 to 0.254
|
POST_HOC outcome
Timeframe: During treatment and up to 30 days after completion of study treatment. Range of cycles 1-32 (1 cycle =28 days).Population: Only patients with a response are included
Duration of response is defined as the time of response to the time of progression for those patients who responded. Response is generally defined as either: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=18 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Duration of Response
|
5.7 months
Interval 3.7 to
upper limit not reached
|
POST_HOC outcome
Timeframe: At 3, 6 and 12 months from initiation of treatmentOS is defined from the start of treatment until date of death from any cause or date of last contact with the probability being calculated at 3, 6 and 12 months.
Outcome measures
| Measure |
Treatment (Tivozanib)
n=30 Participants
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
3, 6 and 12 Month Overall Survival Probability
3 months
|
0.867 probability of patients alive
Interval 0.753 to 0.997
|
|
3, 6 and 12 Month Overall Survival Probability
6 months
|
0.633 probability of patients alive
Interval 0.482 to 0.832
|
|
3, 6 and 12 Month Overall Survival Probability
12 months
|
0.400 probability of patients alive
Interval 0.258 to 0.62
|
Adverse Events
Treatment (Tivozanib)
Serious events: 12 serious events
Other events: 30 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Treatment (Tivozanib)
n=30 participants at risk
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Ileal obstruction
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Stroke
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Ascites
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
Other adverse events
| Measure |
Treatment (Tivozanib)
n=30 participants at risk
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
Tivozanib: 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
12/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Eye disorders
Watering eyes
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
8/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Anal stenosis
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Bloating
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Colonic fistula
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
12/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
9/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Periodontal disease
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Stomach pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
6/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
Chills
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
Fatigue
|
50.0%
15/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
Fever
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
Malaise
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Hepatobiliary disorders
Portal hypertension
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Infections and infestations
Enterocolitis infectious
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
5/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
10/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
26.7%
8/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Creatinine increased
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
INR increased
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Investigations - Other, specify
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
6/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Neutrophil count decreased
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Platelet count decreased
|
23.3%
7/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
Weight loss
|
30.0%
9/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Investigations
White blood cell decreased
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
12/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.3%
4/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.7%
11/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
4/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.3%
7/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.7%
8/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
43.3%
13/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
5/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Metabolism and nutrition disorders
Obesity
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
9/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Hypersomnia
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Paresthesia
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Nervous system disorders
Tremor
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Psychiatric disorders
Confusion
|
16.7%
5/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Renal and urinary disorders
Hematuria
|
23.3%
7/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Renal and urinary disorders
Proteinuria
|
30.0%
9/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Renal and urinary disorders
Urinary urgency
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
10.0%
3/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
5/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
5/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Vascular disorders
Hypertension
|
36.7%
11/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
2/30 • AEs are collected at the beginning of every cycle (1 Cycle = 28 days) during treatment and for 30 days post last treatment. Range of cycles completed by any patient 1-32 cycles. All cause mortality data was collected during both treatment (up to 32 cycles) and follow up (up to a possible 3 years) portions of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place