Trial Outcomes & Findings for Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer (NCT NCT00867321)
NCT ID: NCT00867321
Last Updated: 2022-04-19
Results Overview
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
From baseline up to 3 years post treatment
Results posted on
2022-04-19
Participant Flow
Participant milestones
| Measure |
Arm I (Phase II)
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
Arm II (Phase II)
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
Phase I: Dose Level 0
Patients receive:\> \> Oral 400 mg BID Sorafenib on days 1-28.\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15.
|
Phase I: Dose Level -1
Patients receive:\> \> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2a
Patients receive:\> \> Oral 200 mg BID Sorafenib days 1-28\>
\> 2.5 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2
Patients receive:\> \> Oral 200 mg BID Sorafenib days 1-28\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
6
|
5
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
3
|
6
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Phase II)
n=4 Participants
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
Arm II (Phase II)
n=3 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
All Phase I Patients
n=17 Participants
This includes all patients who participated in the phase I dose escalation portion of the trial.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=93 Participants
|
55 years
n=4 Participants
|
66 years
n=27 Participants
|
60.5 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
17 participants
n=27 Participants
|
24 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 3 years post treatmentPopulation: All eligible patients were treated and analyzed.
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=3 Participants
Patients receive:
\>
\> Oral 400 mg BID Sorafenib on days 1-28.
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15.
|
Phase I: Dose Level -1
n=6 Participants
Patients receive:
\>
\> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2a (Maximum Tolerated Dose)
n=5 Participants
Patients receive:
\>
\> Oral 200 mg BID Sorafenib days 1-28
\>
\> 2.5 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2
n=3 Participants
Patients receive:
\>
\> Oral 200 mg BID Sorafenib days 1-28
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (Phase I)
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 3 years post treatmentPopulation: 6 of 7 patients have had at least one post-baseline assessment of disease and were used for this endpoint.
Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Kaplan-Meier survival curves will be used to estimate the distribution of TTP.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=4 Participants
Patients receive:
\>
\> Oral 400 mg BID Sorafenib on days 1-28.
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15.
|
Phase I: Dose Level -1
n=2 Participants
Patients receive:
\>
\> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2a (Maximum Tolerated Dose)
Patients receive:
\>
\> Oral 200 mg BID Sorafenib days 1-28
\>
\> 2.5 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2
Patients receive:
\>
\> Oral 200 mg BID Sorafenib days 1-28
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
|---|---|---|---|---|
|
Time to Progression (TTP) (Phase II)
|
8.6 years
Interval 0.4 to 16.3
|
13.3 years
Interval 4.4 to
The upper confidence bound was non-estimable.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years post treatmentOverall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up. Kaplan-Meier survival curves will be used to estimate the distribution of OS.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=6 Participants
Patients receive:
\>
\> Oral 400 mg BID Sorafenib on days 1-28.
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15.
|
Phase I: Dose Level -1
Patients receive:
\>
\> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2a (Maximum Tolerated Dose)
Patients receive:
\>
\> Oral 200 mg BID Sorafenib days 1-28
\>
\> 2.5 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2
Patients receive:
\>
\> Oral 200 mg BID Sorafenib days 1-28
\>
\> 1.25 mg/kg Bevacizumab IV on days 1, 15
|
|---|---|---|---|---|
|
Overall Survival
|
13.3 Months
Interval 4.4 to
Upper confidence interval was not reached
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: No patients were analyzed for this endpoint because data was not collected for it
Tumor response (at 6 months) is defined as the number of responses (complete or partial response per Section 11) over the number of eligible patients observed for at least 6 months. Tumor response will be evaluated using simple estimates of proportions.
Outcome measures
Outcome data not reported
Adverse Events
Phase I: Dose Level 0
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Dose Level -1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I: Dose Level -2a
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase I: Dose Level -2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm I (Phase II)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Phase II)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Dose Level 0
n=3 participants at risk
Patients receive:
Oral 400 mg BID Sorafenib on days 1-28.
1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -1
n=6 participants at risk
Patients receive:
Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2a
n=5 participants at risk
Patients receive:
Oral 200 mg BID Sorafenib days 1-28
2.5 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2
n=3 participants at risk
Patients receive:
Oral 200 mg BID Sorafenib days 1-28
1.25 mg/kg Bevacizumab IV on days 1, 15
|
Arm I (Phase II)
n=4 participants at risk
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
Arm II (Phase II)
n=3 participants at risk
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
|---|---|---|---|---|---|---|
|
General disorders
Sudden death
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Investigations
Creatinine increased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
Other adverse events
| Measure |
Phase I: Dose Level 0
n=3 participants at risk
Patients receive:
Oral 400 mg BID Sorafenib on days 1-28.
1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -1
n=6 participants at risk
Patients receive:
Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
1.25 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2a
n=5 participants at risk
Patients receive:
Oral 200 mg BID Sorafenib days 1-28
2.5 mg/kg Bevacizumab IV on days 1, 15
|
Phase I: Dose Level -2
n=3 participants at risk
Patients receive:
Oral 200 mg BID Sorafenib days 1-28
1.25 mg/kg Bevacizumab IV on days 1, 15
|
Arm I (Phase II)
n=4 participants at risk
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
Arm II (Phase II)
n=3 participants at risk
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac disorder
|
33.3%
1/3 • Number of events 6
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Endocrine disorders
Endocrine disorder
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2
|
66.7%
4/6 • Number of events 7
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 10
|
25.0%
1/4 • Number of events 1
|
66.7%
2/3 • Number of events 16
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Edema limbs
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 3
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 7
|
100.0%
6/6 • Number of events 14
|
80.0%
4/5 • Number of events 20
|
100.0%
3/3 • Number of events 8
|
100.0%
4/4 • Number of events 11
|
100.0%
3/3 • Number of events 15
|
|
General disorders
Localized edema
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3
|
16.7%
1/6 • Number of events 3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
|
Investigations
Bilirubin increased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 7
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
33.3%
1/3 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
66.7%
2/3 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Investigations
Lipase increased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Weight loss
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/3
|
33.3%
2/6 • Number of events 3
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Encephalopathy
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
20.0%
1/5 • Number of events 7
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
40.0%
2/5 • Number of events 12
|
66.7%
2/3 • Number of events 14
|
50.0%
2/4 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
66.7%
2/3 • Number of events 4
|
16.7%
1/6 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
66.7%
2/3 • Number of events 7
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
100.0%
4/4 • Number of events 8
|
100.0%
3/3 • Number of events 6
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60