Trial Outcomes & Findings for CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer (NCT NCT02861300)
NCT ID: NCT02861300
Last Updated: 2024-12-19
Results Overview
The Phase I study has been designed to define the recommended phase II dose of CB-839 and capecitabine. A traditional 3+3 dose escalation design will be adopted. Nine to twenty-four patients are expected to be enrolled, depending on the number of dose escalations and assuming that a total of 6 patients will be treated at the final recommended phase II dose level. Patients who complete the first 21 day treatment cycle of CB-839 and capecitabine chemotherapy will be included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
At least 21 days of treatment
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
Phase I Dose -1
* 400 mg CB-839 orally twice daily x 21 days
* 500 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 1
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
3
|
3
|
0
|
7
|
32
|
|
Overall Study
COMPLETED
|
0
|
2
|
3
|
3
|
0
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
1
|
29
|
Reasons for withdrawal
| Measure |
Phase I Dose -1
* 400 mg CB-839 orally twice daily x 21 days
* 500 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 1
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
24
|
|
Overall Study
Delay in treatment
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease Progression
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Patient decision/withdrawal/refusal
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Clinical Complications
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase I Dose -1
* 400 mg CB-839 orally twice daily x 21 days
* 500 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 1
n=3 Participants
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
n=3 Participants
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
n=3 Participants
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
n=7 Participants
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
n=32 Participants
Recommended Phase I dose of CB-839 and capecitabine
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
30-39 years of age
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Age, Customized
40-49 years of age
|
—
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Age, Customized
50-59 years of age
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Age, Customized
60-69 years of age
|
—
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
|
Age, Customized
70-79 years of age
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
—
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Age, Customized
80-89 years of age
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
—
|
5 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
2 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
—
|
7 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
47 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
7 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
—
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
—
|
7 participants
n=8 Participants
|
32 participants
n=8 Participants
|
48 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At least 21 days of treatmentPopulation: Sixteen participants were enrolled in the Phase I portion of this clinical trial.
The Phase I study has been designed to define the recommended phase II dose of CB-839 and capecitabine. A traditional 3+3 dose escalation design will be adopted. Nine to twenty-four patients are expected to be enrolled, depending on the number of dose escalations and assuming that a total of 6 patients will be treated at the final recommended phase II dose level. Patients who complete the first 21 day treatment cycle of CB-839 and capecitabine chemotherapy will be included in the analysis.
Outcome measures
| Measure |
Phase I
n=16 Participants
Phase I dose-escalation study of CB-839 and capecitabine in patients with advanced solid tumors and patients for whom single agent capecitabine is an acceptable treatment option.
|
Phase I Dose 1
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
PHASE I: Recommended Dose for Phase II Study
|
1,000 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome measure is only relevant to Phase II.
The number of participants that achieved PFS will be analyzed. Progression free survival (PFS) on combination CB-839 and capecitabine as determined by clinical assessment and RECIST criteria in patients with metastatic PIK3CA mutant colorectal cancer who are refractory to fluoropyrimidine based therapy. Progression free survival is defined as the time from randomization to documented progression or death without progression.
Outcome measures
| Measure |
Phase I
Phase I dose-escalation study of CB-839 and capecitabine in patients with advanced solid tumors and patients for whom single agent capecitabine is an acceptable treatment option.
|
Phase I Dose 1
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
n=32 Participants
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
PHASE II: Progression-free Survival (PFS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At least 21 days of treatmentPopulation: Two participants were not evaluable were are excluded from Phase I Dose 4. This outcome measure only pertains to Phase I therefore Phase II participants are excluded from analysis.
Disease control rate will be determined using RECIST criteria. RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Phase I
Phase I dose-escalation study of CB-839 and capecitabine in patients with advanced solid tumors and patients for whom single agent capecitabine is an acceptable treatment option.
|
Phase I Dose 1
n=3 Participants
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
n=3 Participants
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
n=3 Participants
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
n=5 Participants
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
PHASE I: Proportion of Patient Who Respond to Treatment
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PHASE I: Proportion of Patient Who Respond to Treatment
Stable Disease
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
PHASE I: Proportion of Patient Who Respond to Treatment
Progressive Disease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
PHASE I: Proportion of Patient Who Respond to Treatment
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months after beginning treatmentPopulation: This outcome measure is only pertaining to Phase I therefore Phase II participants were excluded from the analysis.
Phase I: Dose-limiting toxicities as assessed by CTCAE version 4 of combination CB-839 and capecitabine in patients with advanced solid tumors with no remaining treatment options or patients for whom single agent capecitabine is an acceptable therapy
Outcome measures
| Measure |
Phase I
Phase I dose-escalation study of CB-839 and capecitabine in patients with advanced solid tumors and patients for whom single agent capecitabine is an acceptable treatment option.
|
Phase I Dose 1
n=3 Participants
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
n=3 Participants
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
n=3 Participants
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
n=7 Participants
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
PHASE I: Dose-limiting Toxicities
|
—
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
—
|
0 toxicities
|
—
|
SECONDARY outcome
Timeframe: Up to 18 months after beginning treatmentPopulation: Only 28 of 32 Phase II participants were evaluable for response.
In the phase II component of this study, the primary endpoint is response rate. Disease control rate will be determined using RECIST criteria. RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Phase I
Phase I dose-escalation study of CB-839 and capecitabine in patients with advanced solid tumors and patients for whom single agent capecitabine is an acceptable treatment option.
|
Phase I Dose 1
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
n=28 Participants
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
PHASE II: Number of Patients With Response to Treatment
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PHASE II: Number of Patients With Response to Treatment
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PHASE II: Number of Patients With Response to Treatment
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
|
PHASE II: Number of Patients With Response to Treatment
Progressive Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months after beginning treatmentPopulation: This outcome measure is only relevant to Phase II, therefore no Phase I participants are included in the analysis.
The number of participants to achieve overall survival will be analyzed. Overall survival of patients with metastatic PIK3CA mutant colorectal cancer who are refractory to fluoropyrimidine based therapy following treatment with CB-839 and capecitabine chemotherapy. Overall survival is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Phase I
Phase I dose-escalation study of CB-839 and capecitabine in patients with advanced solid tumors and patients for whom single agent capecitabine is an acceptable treatment option.
|
Phase I Dose 1
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
n=32 Participants
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
PHASE II: Overall Survival
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
Adverse Events
Phase I Dose -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I Dose 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I Dose 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I Dose 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I Dose 3A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I Dose 4
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase II Dose
Serious events: 14 serious events
Other events: 32 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Phase I Dose -1
* 400 mg CB-839 orally twice daily x 21 days
* 500 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 1
n=3 participants at risk
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
n=3 participants at risk
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
n=3 participants at risk
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
n=7 participants at risk
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
n=32 participants at risk
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Lung Infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Abdominal Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Skin Infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Infections and infestations Other, specify: Cholangitis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Colonic obstruction
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Creatinine increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Death NOS
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Infections and infestations Other, specify: Diverticulitis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Fatigue
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Psychiatric disorders
Depression
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Sepsis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions Other, specify: Lactic Acidosis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify: Malignant Biliary Obstruction
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Skin infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
Other adverse events
| Measure |
Phase I Dose -1
* 400 mg CB-839 orally twice daily x 21 days
* 500 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 1
n=3 participants at risk
* 400 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 2
n=3 participants at risk
* 600 mg CB-839 orally twice daily x 21 days
* 750 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3
n=3 participants at risk
* 600 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 3A
* 400 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase I Dose 4
n=7 participants at risk
* 800 mg CB-839 orally twice daily x 21 days
* 1000 mg/m\^2 Capecitabine orally twice daily for 14/21 days
|
Phase II Dose
n=32 participants at risk
Recommended Phase I dose of CB-839 and capecitabine
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nail infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Abdominal distention
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
34.4%
11/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Akathisia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
37.5%
12/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
34.4%
11/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
71.4%
5/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
46.9%
15/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.6%
2/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
37.5%
12/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.6%
2/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
50.0%
16/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Cardiac disorders
Atrial Fibrillation
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
15.6%
5/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Bladder Spasm
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Bloating
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders- Other, specify: Low serum Vitamin D
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
34.4%
11/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Blurred Vision
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Chills
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Hepatobiliary disorders
Cholecystitis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Chronic kidney disease
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Concentration impairment
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.1%
9/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.6%
2/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Creatinine increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
18.8%
6/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Cystitis noninfective
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
15.6%
5/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Psychiatric disorders
Depression
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
43.8%
14/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Dry eye
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Dry mouth
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Dysgeusia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
21.9%
7/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.6%
2/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders Other, specify: Ear congestion
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Edema Limbs
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Esophageal Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye disorder - Other, specify: brighter light around perimeter of vision
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye disorder - Other, specify: Eye heaviness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye disorders - Other, specify: Bilateral eye crusting
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye disorders - Other, specify: NOS
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye disorders - Other, specify: Right eye pruritis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye disorders - Other, specify: Visual auras
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Eye pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Injury, poisoning and procedural complications
Fall
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Fatigue
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
53.1%
17/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Fever
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Flashing lights
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Flatulence
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Injury, poisoning and procedural complications
Fracture
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Gait Disturbance
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Tenesmus
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Gastrointestinal disorders Other, specify- Mouth Sore
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Gastrointestinal disorders- Other, specify: Hard stool
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions Other, Specify- Laceration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions Other, Specify- Lower left quadrant pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions- Other, specify: biopsy site pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions- Other, specify: Body Aches
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions- Other, specify: Generalized Weakness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions- Other,specify:ankle swelling
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
General disorders and administration site conditions: other, specify: Cold Symptoms
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
15.6%
5/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Headache
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
15.6%
5/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Hemorrhoids
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Vascular disorders
Hot flashes
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
34.4%
11/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypertension
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
21.9%
7/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
71.4%
5/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
25.0%
8/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
15.6%
5/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypochloremia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
31.2%
10/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.6%
2/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
25.0%
8/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
100.0%
3/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
100.0%
3/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
43.8%
14/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Hypophosphatemia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
34.4%
11/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypotension
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Hypoxia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Infections and infestations Other, specify: Cold sore
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Infections and infestations Other, specify: Oral thrush
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: NOS
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
INR increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.6%
2/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations - Other, specify: Alkaline phosphatase decreased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations - Other, specify: Low cholesterol
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations - Other, specify: Low Creatinine
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations - Other, specify: Monocyte Count Elevated
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations- Other, specify: Decreased Anion Gap
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations- Other, Specify: Elevated blood urea nitrogen
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Investigations- Other, Specify: Hyperchloremia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Lethargy
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Lipase increased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Vascular disorders
Lymphedema
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
100.0%
3/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
85.7%
6/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
43.8%
14/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Malaise
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Reproductive system and breast disorders
Menorrhagia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders: other, specify- decreased appetite
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Mucositis oral
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
25.0%
8/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Pseudogout
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
56.2%
18/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: NOS
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Nervous system disorders- Other, specify: Increased area of neuropathy
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Nervous system disorders: Other, specify- Neuropathic Extremity
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Neuralgia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Non-cardiac chest pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
General disorders
Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
100.0%
3/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
34.4%
11/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
71.4%
5/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
40.6%
13/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Cardiac disorders
Palpitations
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Papulopustular rash
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Photophobia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
100.0%
3/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
12.5%
4/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Platelet count decreased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
66.7%
2/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
57.1%
4/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
15.6%
5/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Proteinuria
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Rectal pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: NOS
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Renal and urinary disorders- Other, specify: Urinary hesitancy
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Sinus Drainage
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Cardiac disorders
Sinus bradycardia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: cracked skin in corner of mouth
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Finger cut
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: NOS
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Rash to Chest, Neck (occasional pruritus)
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Rash to Chest and Neck-No Pruritis/No Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Skin Discoloration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: two small red spots on her right cheek
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- Other, Specify: Brittle Nails
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- Other, specify: Sores on body
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- Other, specify: Swelling around bilateral big toe nails
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders: Other, specify- Inflammation of Actinic Keratosis
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders: Other, specify: Intertrigo
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Infections and infestations
Skin Infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Nervous system disorders
Somnolence
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urinary fistula
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urinary frequency
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urinary incontinence
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urinary tract pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Renal and urinary disorders
Urine Discoloration
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Vascular disorders
Vascular disorders- Other, specify: Broken capillaries at skin surface
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
85.7%
6/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
28.1%
9/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Eye disorders
Watering eyes
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
6.2%
2/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Weight gain
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
14.3%
1/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
Weight Loss
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
3.1%
1/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
0.00%
0/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
9.4%
3/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
|
Investigations
White blood cell decreased
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
100.0%
3/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
33.3%
1/3 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
—
0/0 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
42.9%
3/7 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
21.9%
7/32 • 18 months after beginning treatment
Arms that enrolled 0 participants have an All-Cause Mortality of zero.
|
Additional Information
Dr. David Bajor
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: (216) 286-4414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place