Trial Outcomes & Findings for Alisertib in Treating Patients With Advanced or Metastatic Sarcoma (NCT NCT01653028)
NCT ID: NCT01653028
Last Updated: 2017-11-30
Results Overview
The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2017-11-30
Participant Flow
From August 2012 to April 2014, a total of 72 patients were accrued to this study (Cohort 1 - 12, Cohort 2 - 10, Cohort 3 - 11, Cohort 4 - 10 Cohort 5 - 29) at a rate of 4.5 patients per month.
Participant milestones
| Measure |
Cohort 1
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort4
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
11
|
10
|
29
|
|
Overall Study
COMPLETED
|
12
|
10
|
11
|
10
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 Participants
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 Participants
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort4
n=10 Participants
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 Participants
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
56.5 years
n=7 Participants
|
66 years
n=5 Participants
|
52.5 years
n=4 Participants
|
49 years
n=21 Participants
|
54.5 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
29 participants
n=21 Participants
|
72 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsThe primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.
Outcome measures
| Measure |
Cohort 1
n=12 Participants
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 Participants
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 Participants
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 4
n=10 Participants
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 Participants
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.
|
0 percentage of patients with response
|
0 percentage of patients with response
|
0 percentage of patients with response
|
0 percentage of patients with response
|
7 percentage of patients with response
|
SECONDARY outcome
Timeframe: The time between registration and death, assessed up to 18 monthsThe distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).
Outcome measures
| Measure |
Cohort 1
n=12 Participants
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 Participants
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 Participants
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 4
n=10 Participants
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 Participants
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Weeks
Interval 23.3 to
Not Reached
|
71.7 Weeks
Interval 16.0 to
Not Reached
|
67.8 Weeks
Interval 19.0 to
Not Reached
|
69 Weeks
Interval 16.0 to
Not Reached
|
28.6 Weeks
Interval 16.6 to 51.3
|
SECONDARY outcome
Timeframe: The time between registration to disease progression or death, assessed up to 18 monthsThe distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).
Outcome measures
| Measure |
Cohort 1
n=12 Participants
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 Participants
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 Participants
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 4
n=10 Participants
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 Participants
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
13 Weeks
Interval 6.29 to 37.1
|
11.7 Weeks
Interval 1.71 to 21.9
|
11.7 Weeks
Interval 5.0 to 20.6
|
13.2 Weeks
Interval 3.57 to 45.0
|
6.57 Weeks
Interval 5.86 to 18.1
|
SECONDARY outcome
Timeframe: During treatment and up to 5 yearsPopulation: All patients that began study treatment were assessed for this endpoint.
Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
Outcome measures
| Measure |
Cohort 1
n=12 Participants
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 Participants
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 Participants
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 4
n=10 Participants
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 Participants
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Adverse Events
Grade 4 Event
|
6 participants
|
1 participants
|
5 participants
|
0 participants
|
4 participants
|
|
Adverse Events
Grade 5 Event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort4
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 5
Serious events: 13 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=12 participants at risk
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 participants at risk
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 participants at risk
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort4
n=10 participants at risk
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 participants at risk
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
2/12 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
6.9%
2/29 • Number of events 3
|
|
Gastrointestinal disorders
Typhlitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
13.8%
4/29 • Number of events 5
|
|
General disorders
Fatigue
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Infections and infestations
Sepsis
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Infections and infestations
Wound infection
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
INR increased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
13.8%
4/29 • Number of events 5
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Investigations
Serum amylase increased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
White blood cell decreased
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
16.7%
2/12 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 2
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2
n=10 participants at risk
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3
n=11 participants at risk
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort4
n=10 participants at risk
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 5
n=29 participants at risk
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
10/12 • Number of events 32
|
40.0%
4/10 • Number of events 15
|
63.6%
7/11 • Number of events 44
|
60.0%
6/10 • Number of events 15
|
51.7%
15/29 • Number of events 37
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Eye disorders
Blurred vision
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 4
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 3
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Eye disorders
Eye pain
|
8.3%
1/12 • Number of events 4
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Eye disorders
Watering eyes
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 3
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/29
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 4
|
9.1%
1/11 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
10.3%
3/29 • Number of events 12
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • Number of events 9
|
20.0%
2/10 • Number of events 5
|
36.4%
4/11 • Number of events 15
|
60.0%
6/10 • Number of events 16
|
37.9%
11/29 • Number of events 28
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
4/12 • Number of events 6
|
40.0%
4/10 • Number of events 4
|
36.4%
4/11 • Number of events 5
|
50.0%
5/10 • Number of events 8
|
37.9%
11/29 • Number of events 28
|
|
Gastrointestinal disorders
Nausea
|
50.0%
6/12 • Number of events 27
|
10.0%
1/10 • Number of events 2
|
36.4%
4/11 • Number of events 11
|
50.0%
5/10 • Number of events 7
|
24.1%
7/29 • Number of events 24
|
|
Gastrointestinal disorders
Oral hemorrhage
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/29
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 9
|
0.00%
0/10
|
18.2%
2/11 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
10.3%
3/29 • Number of events 7
|
|
General disorders
Chills
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Facial pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
General disorders
Fatigue
|
83.3%
10/12 • Number of events 42
|
60.0%
6/10 • Number of events 16
|
36.4%
4/11 • Number of events 12
|
60.0%
6/10 • Number of events 12
|
44.8%
13/29 • Number of events 39
|
|
General disorders
Fever
|
0.00%
0/12
|
0.00%
0/10
|
18.2%
2/11 • Number of events 7
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Flu like symptoms
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Localized edema
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 3
|
0.00%
0/29
|
|
General disorders
Pain
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
6.9%
2/29 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 3
|
20.0%
2/10 • Number of events 3
|
6.9%
2/29 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/12
|
20.0%
2/10 • Number of events 2
|
9.1%
1/11 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
13.8%
4/29 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
20.0%
2/10 • Number of events 2
|
13.8%
4/29 • Number of events 5
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 5
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/12
|
10.0%
1/10 • Number of events 2
|
0.00%
0/11
|
20.0%
2/10 • Number of events 3
|
0.00%
0/29
|
|
Investigations
INR increased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
33.3%
4/12 • Number of events 11
|
40.0%
4/10 • Number of events 4
|
18.2%
2/11 • Number of events 22
|
40.0%
4/10 • Number of events 5
|
24.1%
7/29 • Number of events 23
|
|
Investigations
Neutrophil count decreased
|
50.0%
6/12 • Number of events 26
|
50.0%
5/10 • Number of events 9
|
72.7%
8/11 • Number of events 20
|
50.0%
5/10 • Number of events 7
|
58.6%
17/29 • Number of events 41
|
|
Investigations
Platelet count decreased
|
41.7%
5/12 • Number of events 29
|
50.0%
5/10 • Number of events 15
|
54.5%
6/11 • Number of events 19
|
30.0%
3/10 • Number of events 5
|
48.3%
14/29 • Number of events 66
|
|
Investigations
Serum amylase increased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Investigations
Weight loss
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Investigations
White blood cell decreased
|
58.3%
7/12 • Number of events 35
|
40.0%
4/10 • Number of events 6
|
54.5%
6/11 • Number of events 38
|
60.0%
6/10 • Number of events 9
|
41.4%
12/29 • Number of events 45
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
18.2%
2/11 • Number of events 8
|
20.0%
2/10 • Number of events 2
|
13.8%
4/29 • Number of events 21
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
0.00%
0/10
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
27.3%
3/11 • Number of events 12
|
30.0%
3/10 • Number of events 7
|
6.9%
2/29 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
2/12 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
27.3%
3/11 • Number of events 11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/10
|
18.2%
2/11 • Number of events 3
|
0.00%
0/10
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
13.8%
4/29 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
0.00%
0/10
|
0.00%
0/29
|
|
Nervous system disorders
Amnesia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 3
|
|
Nervous system disorders
Ataxia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
3.4%
1/29 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 3
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
20.0%
2/10 • Number of events 3
|
10.3%
3/29 • Number of events 7
|
|
Nervous system disorders
Seizure
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/29
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12
|
10.0%
1/10 • Number of events 2
|
27.3%
3/11 • Number of events 6
|
40.0%
4/10 • Number of events 6
|
24.1%
7/29 • Number of events 15
|
|
Nervous system disorders
Syncope
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
6.9%
2/29 • Number of events 3
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
0.00%
0/10
|
3.4%
1/29 • Number of events 3
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 4
|
0.00%
0/29
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 3
|
0.00%
0/29
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 5
|
0.00%
0/29
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
0.00%
0/29
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • Number of events 4
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 4
|
10.0%
1/10 • Number of events 4
|
10.3%
3/29 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12
|
0.00%
0/10
|
18.2%
2/11 • Number of events 6
|
10.0%
1/10 • Number of events 5
|
6.9%
2/29 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.3%
7/12 • Number of events 37
|
40.0%
4/10 • Number of events 19
|
72.7%
8/11 • Number of events 44
|
80.0%
8/10 • Number of events 24
|
58.6%
17/29 • Number of events 79
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
3/12 • Number of events 10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
10.0%
1/10 • Number of events 2
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
20.0%
2/10 • Number of events 3
|
13.8%
4/29 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 22
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
3/12 • Number of events 4
|
10.0%
1/10 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
0.00%
0/10
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.3%
1/12 • Number of events 5
|
0.00%
0/10
|
9.1%
1/11 • Number of events 4
|
0.00%
0/10
|
3.4%
1/29 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • Number of events 4
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
0.00%
0/29
|
|
Vascular disorders
Hypertension
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
3.4%
1/29 • Number of events 4
|
|
Vascular disorders
Thromboembolic event
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/29
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/10
|
3.4%
1/29 • Number of events 1
|
Additional Information
Mark Andrew Dickson M.D.
Memorial Sloan Kettering Cancer Center
Phone: 6468884164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60