Trial Outcomes & Findings for VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors (NCT NCT01784861)
NCT ID: NCT01784861
Last Updated: 2021-07-08
Results Overview
Tolerability of X-82 in combination with everolimus will be determined by NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Completion of 1st cycle for all patients in Phase I portion of study (completed in approximately 20 months)
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
8
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
5
|
1
|
1
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
1
|
Baseline Characteristics
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
n=3 Participants
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
n=3 Participants
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
n=4 Participants
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
n=8 Participants
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
n=3 Participants
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=2 Participants
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
71 years
n=99 Participants
|
61 years
n=107 Participants
|
53 years
n=206 Participants
|
53 years
n=7 Participants
|
59 years
n=31 Participants
|
64.5 years
n=30 Participants
|
59 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
3 participants
n=31 Participants
|
2 participants
n=30 Participants
|
23 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Completion of 1st cycle for all patients in Phase I portion of study (completed in approximately 20 months)Population: -1 participant in Phase I Dose Level 2 was not evaluable for this outcome measure because they received less than one cycle of treatment. 1 participant in Phase I Dose Level 3 was not evaluable for this outcome measure because they received less than one cycle of treatment. 1 participant in Phase I Dose Level 3 was not evaluable for this outcome measure because they didn't receive any treatment.
Tolerability of X-82 in combination with everolimus will be determined by NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
n=3 Participants
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
n=3 Participants
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
n=3 Participants
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
n=6 Participants
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
n=3 Participants
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities - Phase I
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days after completion of treatment (estimated to be 13 months)Population: Phase II is zero analyzed because this outcome measure is for Phase I participants only.
-Toxicities will be graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
n=3 Participants
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
n=3 Participants
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
n=4 Participants
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
n=8 Participants
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
n=3 Participants
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Overall Toxicities - Phase I
Anemia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hearing impaired
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Peripheral vision/depth perception impairment
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Abdominal distension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Abdominal pain
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
|
Overall Toxicities - Phase I
Colonic fistula
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Constipation
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Diarrhea
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Overall Toxicities - Phase I
Dry mouth
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Dyspepsia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Flatulence
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hemorrhoids
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Intra-abdominal hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Loss of taste
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Mucositis oral
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Overall Toxicities - Phase I
Nausea
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Rectal fissure
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Stomach pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Taste changes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Vomiting
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Chills
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Edema face
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Edema limbs
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Fatigue
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
—
|
|
Overall Toxicities - Phase I
Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Pain
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Cold sores
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Elevated lactate dehydrogenase total
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Oral thrush
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Peritoneal infection
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Sinusitis
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Upper respiratory infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Urinary tract infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Bruising
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Slow wound healing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Weight loss
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Anorexia
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Overall Toxicities - Phase I
Dehydration
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Overall Toxicities - Phase I
Hypernatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Hypertriglyceridemia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Hypophosphatemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Arthralgia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Back pain
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Flank pain
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Pain to extremity
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Aphasia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Dizziness
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Dysgeusia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Headache
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Tremor
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Trigeminal nerve disorder
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Anxiety
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Confusion
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Depression
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Insomnia
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Libido decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Mood swings
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hematuria
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Urinary frequency
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Testicular pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Cough
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Dyspnea
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Epistaxis
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hiccups
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hypoxia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Nasal congestion
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Sore throat
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Alopecia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hair color changes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Pruritis
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Rash acneiform
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Rash maculo-papular
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Skin hypopigmentation
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Skin thinning
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Hot flashes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Dysphagia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Hypovolemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Intraperitoneal bleeding
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Night sweats
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Thromboembolic event
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Lung infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Pancreas infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Overall Toxicities - Phase I
Sepsis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Diabetic ketoacidosis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Stroke
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Pleural effusion
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Toxicities - Phase I
Mesenteric ischemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Completion of 1st cycle for all patients in Phase I portion of study (completed in approximately 20 months)Population: This was the recommended Phase II dose because there were concerns about the ability to maintain the 400 mg daily dosing level for multiple cycles without significant toxicity.
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
n=21 Participants
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Recommended Phase II Dose of X-82
|
300 mg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through completion of treatment (estimated to be 12 months)Population: Phase I participants are not evaluable for this outcome measure. One participant in the Phase II portion of the study was not evaluable because the treating physician removed the participant from the treatment prior to receiving the end of cycle 3 imaging.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=1 Participants
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (Complete Response + Partial Response) - Phase II
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Through completion of treatment (estimated to be 12 months)Population: Phase I participants are not evaluable for this outcome measure. One participant in the Phase II portion of the study was not evaluable because the treating physician removed the participant from the treatment prior to receiving the end of cycle 3 imaging.
* Disease stabilization rate is defined as the proportion of patients achieving a best overall response of complete response, partial response, or stable disease. * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=1 Participants
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Disease Stabilization Rate - Phase II
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Phase I participants are not evaluable for this outcome measure.
* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=2 Participants
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) - Phase II
|
—
|
—
|
—
|
—
|
—
|
183 days
Interval 174.0 to 192.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Phase I participants are not evaluable for this outcome measure.
Start of the treatment until death.
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=2 Participants
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Overall Survival - Phase II
|
—
|
—
|
—
|
—
|
—
|
115 days
Interval 94.0 to 136.0
|
SECONDARY outcome
Timeframe: Through 30 days after completion of treatment (estimated to be 13 months)Population: Phase I participants are not evaluable for this outcome measure.
Toxicity will be graded by NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Outcome measures
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=2 Participants
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Number of Participants With Toxicity - Phase II
Diarrhea
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Toxicity - Phase II
Mucositis oral
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Nausea
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Vomiting
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Chest pain
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Edema limbs
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Hematoma
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Mouth sores
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Creatinine increased
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Platelet count decreased
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Hip pain
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Leg cramps
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Dizziness
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Headache
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Allergic rhinitis
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Rash acneiform
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Rash maculo-papular
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Toxicity - Phase II
Hypertension
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
Adverse Events
Phase I Dose Level 0: X-82 + Everolimus
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Dose Level 1: X-82 + Everolimus
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Dose Level 2: X-82 + Everolimus
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase I Dose Level 3: X-82 + Everolimus
Serious events: 2 serious events
Other events: 8 other events
Deaths: 5 deaths
Phase I Dose Level 4: X-82 + Everolimus
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase II: X-82 + Everolimus
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
n=3 participants at risk
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
n=3 participants at risk
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
n=4 participants at risk
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
n=8 participants at risk
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
n=3 participants at risk
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=2 participants at risk
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Hematoma
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Oral thrush
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Stroke
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Hypovolemia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Intraperitoneal bleeding
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Mesenteric ischemia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
Other adverse events
| Measure |
Phase I Dose Level 0: X-82 + Everolimus
n=3 participants at risk
* X-82 100 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 1: X-82 + Everolimus
n=3 participants at risk
* X-82 150 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 2: X-82 + Everolimus
n=4 participants at risk
* X-82 200 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 3: X-82 + Everolimus
n=8 participants at risk
* X-82 300 mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* Everolimus and X-82 should be taken at the same time every day
* 28 days =1 cycle
|
Phase I Dose Level 4: X-82 + Everolimus
n=3 participants at risk
* Everolimus 10mg by mouth once daily for each cycle MUST BE TAKEN FIRST
* X-82 400 mg by mouth once daily 2 HOURS AFTER everolimus dose
* 28 days =1 cycle
X-82
Everolimus
|
Phase II: X-82 + Everolimus
n=2 participants at risk
* X-82 (dose determined by Phase I portion to be 300 mg) mg by mouth once daily
* Everolimus 10mg by mouth once daily for each cycle
* 28 days =1 cycle
|
|---|---|---|---|---|---|---|
|
Investigations
Weight loss
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Ear and labyrinth disorders
Hearing impaired
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Eye disorders
Peripheral vision/depth perception impairment
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
4/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
66.7%
2/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
100.0%
2/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Loss of taste
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
66.7%
2/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
4/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
66.7%
2/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Taste changes
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Edema face
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
4/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
66.7%
2/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
75.0%
3/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
62.5%
5/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
66.7%
2/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Cold sores
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Elevated lactate dehydrogenase total
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Mouth sores
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Injury, poisoning and procedural complications
Slow wound healing
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
4/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
75.0%
3/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
100.0%
3/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain to extremity
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Aphasia
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
37.5%
3/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
2/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
2/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin thinning
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
25.0%
1/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
50.0%
1/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Night sweats
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
33.3%
1/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/4 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
12.5%
1/8 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/3 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
0.00%
0/2 • Adverse events were followed from start of treatment through 30 days following end of treatment. All-cause mortality was followed from start of treatment through completion of follow-up.
|
Additional Information
Benjamin Tan, M.D.
Washington University School of Medicine
Phone: 314-362-5740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place