Trial Outcomes & Findings for Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer (NCT NCT03542877)
NCT ID: NCT03542877
Last Updated: 2022-07-15
Results Overview
A patient is classified as progression-free if s/he is assessed as not having progressive disease (PD) as defined per RECIST 1.1 criteria at either the 12-week assessment or after having at least 11 weeks of treatment for subjects without the 12-week assessment. Censored patients (i.e. those who have not progressed but who are missing a 12-week assessment) are not included in the analysis. Subjects who didn't have the 12-week assessment but who had clinical progression were included and considered to have progressed. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.
Results posted on
2022-07-15
Participant Flow
Participant milestones
| Measure |
Oral Cabozantinib
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Oral Cabozantinib
n=44 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 23 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.Population: 40 of the 44 subjects were in the analysis population. 3 subjects were not included because they didn't have treatment response data, and 1 subject was not included because that subject didn't reach at least week 11 (and didn't have PD).
A patient is classified as progression-free if s/he is assessed as not having progressive disease (PD) as defined per RECIST 1.1 criteria at either the 12-week assessment or after having at least 11 weeks of treatment for subjects without the 12-week assessment. Censored patients (i.e. those who have not progressed but who are missing a 12-week assessment) are not included in the analysis. Subjects who didn't have the 12-week assessment but who had clinical progression were included and considered to have progressed. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Oral Cabozantinib
n=40 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
Subjects with wild type RAS mutation status
|
|---|---|---|
|
12-Week Progression Free Survival
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.Population: This population was the same as the population for the primary analysis
This has the same outcome measure description as the primary analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Oral Cabozantinib
n=22 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
n=18 Participants
Subjects with wild type RAS mutation status
|
|---|---|---|
|
12-Week Progression-Free Survival by RAS Mutation Status
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.Population: All subjects in the primary analysis who had data regarding their PIK3CA mutation status.
This has the same outcome measure description as the primary analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Oral Cabozantinib
n=6 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
n=22 Participants
Subjects with wild type RAS mutation status
|
|---|---|---|
|
12-Week Progression-Free Survival by PIK3CA Mutation Status
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: 3 of the 44 study subjects were not included in this analysis population because they didn't have treatment response data.
Progression-free survival will be defined as the time from administration of the initial dose of cabozantinib to evidence of radiographic progression as defined by RECIST criteria or death from any cause without evidence of disease progression, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Oral Cabozantinib
n=41 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
13 Weeks
Interval 9.0 to 21.0
|
—
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: 3 of the 44 study subjects were not included in this analysis population because they didn't have treatment response data.
This has the same outcome measure description as the PFS analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Oral Cabozantinib
n=23 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
n=18 Participants
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Progression-Free Survival (PFS) by RAS Mutation Status
|
12 Weeks
Interval 6.0 to 14.0
|
21 Weeks
Interval 9.0 to 48.0
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: All subjects in the PFS secondary analysis who had data regarding their PIK3CA mutation status.
This has the same outcome measure description as the PFS analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Oral Cabozantinib
n=7 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
n=22 Participants
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Progression-Free Survival (PFS) by PIK3CA Mutation Status
|
26 Weeks
Interval 5.0 to
The upper limit of this 95% CI is infinity (and the entry 'Infinity' cannot be made)
|
20 Weeks
Interval 6.0 to 29.0
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: This analysis population was the same as described for the primary analysis.
\*A patient is classified as a responder if s/he is assessed as having complete response or partial response (CR or PR) at the time of any assessment, where CR and PR are defined per RECIST 1.1 criteria.
Outcome measures
| Measure |
Oral Cabozantinib
n=40 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Response Rate in Patients With CRC Treated With Cabozantinib
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: All 34 subjects with follow-up data (i.e. data in the 'dataset\_survival\_follow\_up.xlsx' table) were included in the analysis.
Overall Survival will be defined as the time from administration of the initial dose of cabozantinib until death from any cause.
Outcome measures
| Measure |
Oral Cabozantinib
n=34 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Overall Survival (OS) in Patients With CRC Treated With Cabozantinib
|
36 Weeks
Interval 24.0 to 50.0
|
—
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: All 34 subjects with follow-up data (i.e. data in the 'dataset\_survival\_follow\_up.xlsx' table) were included in the analysis.
This has the same outcome measure description as the OS analysis.
Outcome measures
| Measure |
Oral Cabozantinib
n=19 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
n=15 Participants
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Overall Survival (OS) by RAS Mutation Status
|
30 Weeks
Interval 18.0 to 46.0
|
45 Weeks
Interval 20.0 to
The upper limit of the 95% CI is Infinity (which isn't an acceptable entry above)
|
SECONDARY outcome
Timeframe: Study start date to study end date, or death, whichever comes first, up to 24 monthsPopulation: All subjects in the secondary OS analysis who had data regarding their PIK3CA mutation status.
This has the same outcome measure description as the OS analysis.
Outcome measures
| Measure |
Oral Cabozantinib
n=5 Participants
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
RAS Wild Type
n=17 Participants
Subjects with wild type RAS mutation status
|
|---|---|---|
|
Overall Survival (OS) by PIK3CA Mutation Status
|
92 Weeks
Interval 9.0 to
The upper limit of the 95% CI is Infinity (which is not an acceptable entry above)
|
36 Weeks
Interval 20.0 to 85.0
|
Adverse Events
Oral Cabozantinib
Serious events: 20 serious events
Other events: 43 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Oral Cabozantinib
n=44 participants at risk
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cavitating Pulmonary Nodules
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Acute Cerebrovascular Accident
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Acute Renal Failure
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Back Pain
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Bowel Perforation
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 2 • 45 months
|
|
General disorders
Dehydration
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
difficulty speaking
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Disease Progression
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Duodenal fistula
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Failure to Thrive
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
GI bleed
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Gastrointestinal disorders
nausea
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Bowel Obstruction
|
2.3%
1/44 • Number of events 2 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.8%
3/44 • Number of events 4 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Progressed Malignant Neoplasm
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Severe Complicated Bilateral Pyelonephritis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Number of events 2 • 45 months
|
Other adverse events
| Measure |
Oral Cabozantinib
n=44 participants at risk
Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.
Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
36.4%
16/44 • Number of events 19 • 45 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.3%
1/44 • Number of events 2 • 45 months
|
|
Gastrointestinal disorders
Acid Reflux
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
15.9%
7/44 • Number of events 8 • 45 months
|
|
General disorders
Alopecia
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Blood and lymphatic system disorders
alanine aminotransferase increase
|
15.9%
7/44 • Number of events 10 • 45 months
|
|
Blood and lymphatic system disorders
Amylase increased
|
6.8%
3/44 • Number of events 4 • 45 months
|
|
Blood and lymphatic system disorders
Anemia
|
15.9%
7/44 • Number of events 8 • 45 months
|
|
General disorders
Anorexia
|
36.4%
16/44 • Number of events 26 • 45 months
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
20.5%
9/44 • Number of events 19 • 45 months
|
|
General disorders
Hearing Loss
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Edema
|
20.5%
9/44 • Number of events 12 • 45 months
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Proteinuria
|
27.3%
12/44 • Number of events 20 • 45 months
|
|
Blood and lymphatic system disorders
Hypertension
|
34.1%
15/44 • Number of events 31 • 45 months
|
|
Skin and subcutaneous tissue disorders
Mouth Sores
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Nausea
|
38.6%
17/44 • Number of events 19 • 45 months
|
|
Blood and lymphatic system disorders
Elevated Creatinine
|
9.1%
4/44 • Number of events 5 • 45 months
|
|
Gastrointestinal disorders
Constipation
|
31.8%
14/44 • Number of events 15 • 45 months
|
|
Gastrointestinal disorders
Diarrhea
|
52.3%
23/44 • Number of events 33 • 45 months
|
|
Blood and lymphatic system disorders
Hypokalemia
|
18.2%
8/44 • Number of events 11 • 45 months
|
|
Skin and subcutaneous tissue disorders
Mouth Sensitivity
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Skin and subcutaneous tissue disorders
Skin sensitivity
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Endocrine disorders
Hypothyroidism
|
22.7%
10/44 • Number of events 11 • 45 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.6%
6/44 • Number of events 9 • 45 months
|
|
General disorders
sinusitis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Bloating
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Gastrointestinal disorders
vomiting
|
27.3%
12/44 • Number of events 17 • 45 months
|
|
General disorders
Fatigue
|
63.6%
28/44 • Number of events 48 • 45 months
|
|
General disorders
chest pain
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
18.2%
8/44 • Number of events 9 • 45 months
|
|
Cardiac disorders
Elevated troponin
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
fecal impaction
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
sore throat
|
13.6%
6/44 • Number of events 7 • 45 months
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
22.7%
10/44 • Number of events 11 • 45 months
|
|
General disorders
hoarse
|
9.1%
4/44 • Number of events 4 • 45 months
|
|
Skin and subcutaneous tissue disorders
palmar-plantar erythrodysesthesia
|
31.8%
14/44 • Number of events 35 • 45 months
|
|
General disorders
Chills
|
9.1%
4/44 • Number of events 4 • 45 months
|
|
General disorders
fever
|
18.2%
8/44 • Number of events 9 • 45 months
|
|
General disorders
forgetfulness
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Gastrointestinal disorders
Reflux
|
20.5%
9/44 • Number of events 9 • 45 months
|
|
Blood and lymphatic system disorders
Elevated Liver Function Test
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Infections and infestations
Sepsis
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
11.4%
5/44 • Number of events 5 • 45 months
|
|
Nervous system disorders
Neuropathy
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Cardiac disorders
Tachycardia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Lactate Increased
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Gastrointestinal disorders
Flatulence
|
11.4%
5/44 • Number of events 5 • 45 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.4%
5/44 • Number of events 5 • 45 months
|
|
General disorders
Abdominal Tenderness
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Pain
|
38.6%
17/44 • Number of events 38 • 45 months
|
|
General disorders
Ache
|
13.6%
6/44 • Number of events 9 • 45 months
|
|
Gastrointestinal disorders
Distended Abdomen
|
4.5%
2/44 • Number of events 3 • 45 months
|
|
General disorders
Weakness
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Skin and subcutaneous tissue disorders
Xerostomia
|
9.1%
4/44 • Number of events 4 • 45 months
|
|
Blood and lymphatic system disorders
Hyperamylasemia
|
11.4%
5/44 • Number of events 7 • 45 months
|
|
General disorders
Decreased Appetite
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Congestion
|
6.8%
3/44 • Number of events 4 • 45 months
|
|
General disorders
Bleeding gums
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Malnutrition
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Metabolism and nutrition disorders
Weight loss
|
31.8%
14/44 • Number of events 19 • 45 months
|
|
General disorders
Dizziness
|
15.9%
7/44 • Number of events 9 • 45 months
|
|
General disorders
Dysgeusia
|
15.9%
7/44 • Number of events 7 • 45 months
|
|
General disorders
Cough
|
15.9%
7/44 • Number of events 9 • 45 months
|
|
Infections and infestations
Infection
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Hematuria
|
15.9%
7/44 • Number of events 10 • 45 months
|
|
Endocrine disorders
TSH elevated
|
9.1%
4/44 • Number of events 4 • 45 months
|
|
Skin and subcutaneous tissue disorders
epistaxis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Cardiac disorders
Hypotension
|
4.5%
2/44 • Number of events 3 • 45 months
|
|
Blood and lymphatic system disorders
Bilirubin Increased
|
13.6%
6/44 • Number of events 12 • 45 months
|
|
Cardiac disorders
bradycardia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Cardiac disorders
Syncope
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Gait Disturbance
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Dysesthesia
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Hypersomnia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Blurred vision
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Metabolism and nutrition disorders
Weight Gain
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Hyperuricemia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Cardiac disorders
Conduction Disorder
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Skin and subcutaneous tissue disorders
hypopigmentation
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Dental Caries
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Blood and lymphatic system disorders
Hyperlipasemia
|
9.1%
4/44 • Number of events 5 • 45 months
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Hyponatremia
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Endocrine disorders
Hyperglycemia
|
6.8%
3/44 • Number of events 4 • 45 months
|
|
Blood and lymphatic system disorders
Hypernatremia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
9.1%
4/44 • Number of events 4 • 45 months
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.6%
6/44 • Number of events 9 • 45 months
|
|
Blood and lymphatic system disorders
Ascites
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Urinary Retention
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.8%
3/44 • Number of events 3 • 45 months
|
|
Infections and infestations
Tonsilitis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
6/44 • Number of events 6 • 45 months
|
|
Psychiatric disorders
Mood alteration
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Vascular disorders
Hypertention
|
6.8%
3/44 • Number of events 8 • 45 months
|
|
Skin and subcutaneous tissue disorders
Numbness of skin
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Renal and urinary disorders
Elevated Urine Protein Creatinine Ratio
|
4.5%
2/44 • Number of events 4 • 45 months
|
|
Renal and urinary disorders
Increased Creatinine
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Migraine
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
General disorders
Change in Hair Color
|
4.5%
2/44 • Number of events 3 • 45 months
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Skin and subcutaneous tissue disorders
Burning mouth syndrom
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Injury, poisoning and procedural complications
Wound bleeding
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
2.3%
1/44 • Number of events 2 • 45 months
|
|
Renal and urinary disorders
Urine Discoloration
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Dehydration
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Hepatobiliary disorders
Jaundice
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Infections and infestations
Pancreatitis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Neurological Changes
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Vascular disorders
Shock
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Tumor Lysis Syndrome
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
General disorders
Diaphoresis
|
2.3%
1/44 • Number of events 1 • 45 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
2/44 • Number of events 2 • 45 months
|
|
Infections and infestations
Laryngitis
|
2.3%
1/44 • Number of events 1 • 45 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place