Trial Outcomes & Findings for Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (NCT NCT01222689)
NCT ID: NCT01222689
Last Updated: 2020-07-31
Results Overview
Survival will be calculated according to the method of Kaplan and Meier. Both actual and estimated probability of being alive (along with a 95% confidence interval) at 24 weeks (6 months) and for any multiple of 6 months will be calculated for which the number of uncensored subjects is not smaller than 10.
COMPLETED
PHASE2
46 participants
Up to 2 years
2020-07-31
Participant Flow
Participant milestones
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 Participants
Patients receive selumetinib by mouth (PO) every day (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Prior chemotherapy
Gemcitabine-based
|
34 participants
n=5 Participants
|
|
Prior chemotherapy
FOLFIRINOX
|
10 participants
n=5 Participants
|
|
Prior chemotherapy
Other
|
2 participants
n=5 Participants
|
|
Prior surgery
|
14 participants
n=5 Participants
|
|
Prior radiation
|
7 participants
n=5 Participants
|
|
Elevated baseline Cancer Antigen 19-9(CA19-9) > 2x Upper Limit of Normal (ULN)
|
34 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
status = 0
|
32 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
status = 1
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsSurvival will be calculated according to the method of Kaplan and Meier. Both actual and estimated probability of being alive (along with a 95% confidence interval) at 24 weeks (6 months) and for any multiple of 6 months will be calculated for which the number of uncensored subjects is not smaller than 10.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS)
|
7.3 months
Interval 5.2 to 8.0
|
PRIMARY outcome
Timeframe: 24 weeksPercent survival at 24 weeks (6 months)
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Survival at 24 Weeks
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the date of objective progression, or death due to cancer or unknown cause, or to the date of withdrawal from the trial from unknown reasons, assessed up to 2 yearsCalculated according to the method of Kaplan and Meier. Actual and estimated probability of being alive and progression-free, along with a 95% confidence interval, will be calculated. Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(Macdonald et al.):205-216, 2000\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used. Progressive Disease is defined as a 20% or higher 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. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival (PFS)
|
1.9 months
Interval 1.4 to 3.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with baseline levels \> 2 x ULN CA19-9 measurement
The proportion of patients with CA19-9 response.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=34 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement)
|
38 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: There were no complete or patial responses by RECIST (stable disease, partial response, or complete response) amongst the 46 participants
Patient's best overall response will be tabulated by level; proportions of complete response (CR) and of CR+partial response will be calculated along with 95% confidence intervals. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR, \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Radiographic Response by RECIST Criteria
Complete Response (CR)
|
0 participants
|
|
Objective Radiographic Response by RECIST Criteria
Complete+Partial Response
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentTabulation of type of adverse events (AE) and the incidence of grade 3 and 4 for each AE
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anemia
|
5 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dysgeusia
|
0 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Eye disorders
|
0 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Rash
|
10 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea
|
6 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nausea/vomiting
|
4 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fatigue
|
3 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
AST/ALT elevation
|
4 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anorexia
|
0 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pruritus
|
0 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypertension
|
6 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Thrombocytopenia
|
1 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Leukopenia/neutropenia
|
1 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Thromboembolic event (incl. cerebral)
|
3 events
|
|
Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Elevated creatinine
|
0 events
|
SECONDARY outcome
Timeframe: Up to final day of study treatmentPopulation: Numbers in tabulation total to more than 18 because patients often had 2 or more reasons that prompted dose reduction. For example: Nausea/Vomiting + diarrhea (3), fatigue + diarrhea (2), rash + hypertension (1), rash + diarrhea (1), fatigue + Nausea/Vomiting (1)
Tabulation of the reasons for dose modification with number of patients
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=18 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
RASH
|
8 participants
|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
Diarrhea
|
7 participants
|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
NAUSEA/VOMITING
|
5 participants
|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
Fatigue
|
3 participants
|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
Hypertension
|
1 participants
|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
TRANSAMINITIS
|
1 participants
|
|
Number of Patients With Dose Modifications and Reason for Dose Modification.
UNKNOWN
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Data was not collected.
Logistic regression models will be used to associate baseline protein markers and best objective response. Cox models will be used to associate baseline protein markers with overall and progression-free survival. Each selected protein markers will be evaluated individually and ranked by the corresponding p-values. Combinations of markers will also be explored.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Data was not collected.
The association between baseline CTC numbers, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response will be evaluated. The association between expression level of protein markers in CTC with biopsy samples using Pearson's correlation and by unsupervised hierarchical clustering of samples using Pearson correlation as the distance metric will be assessed. Association of longitudinal protein markers in CTC with patient OS will be evaluated using the joint models of longitudinal observations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Patients who had non-germline mutations (circulating cell-free DNA) represented in both their pre-treatment blood and on-treatment blood samples.
The association between candidate plasma biomarkers of interest, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response. Specifically, correlation of the relative change in allelic frequency of mutations present in both pre-treatment and on-treatment blood samples versus percent change in CA19-9.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=24 Participants
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Plasma Biomarkers Potentially Predictive of Dual MEK/EGFR Inhibition
|
0.1369 R^2
|
Adverse Events
Treatment (Erlotinib Hydrochloride, Selumetinib)
Serious adverse events
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 participants at risk
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Acites
|
6.5%
3/46
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
4/46
|
|
Blood and lymphatic system disorders
edema
|
2.2%
1/46
|
|
Gastrointestinal disorders
fatigue
|
23.9%
11/46
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
dehydration
|
8.7%
4/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify - disease progr
|
15.2%
7/46
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.5%
3/46
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
2.2%
1/46
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46
|
|
Gastrointestinal disorders
Esophageal varicies hemorrhage
|
2.2%
1/46
|
|
Cardiac disorders
Cardiac disorder
|
2.2%
1/46
|
|
General disorders
Pain
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
anemia
|
4.3%
2/46
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
2/46
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
3/46
|
|
Investigations
Alanine Aminotransferase increae
|
2.2%
1/46
|
|
Investigations
Alkaline phosphastase increase
|
2.2%
1/46
|
|
Investigations
blood bilirubin increase
|
2.2%
1/46
|
|
Investigations
Aspartate aminotransferase increase
|
2.2%
1/46
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
2/46
|
|
General disorders
Chills
|
2.2%
1/46
|
|
General disorders
Fever
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnea
|
2.2%
1/46
|
|
Infections and infestations
Abdominal Infection
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.2%
1/46
|
|
Psychiatric disorders
Confusion - acute dementia
|
2.2%
1/46
|
|
Psychiatric disorders
Delusion - acute dementia
|
2.2%
1/46
|
|
Gastrointestinal disorders
Small intestine ulcer
|
2.2%
1/46
|
Other adverse events
| Measure |
Treatment (Erlotinib Hydrochloride, Selumetinib)
n=46 participants at risk
Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.3%
13/46
|
|
Blood and lymphatic system disorders
Elevated white blood cell count
|
2.2%
1/46
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/46
|
|
Eye disorders
Blurred vision
|
6.5%
3/46
|
|
Eye disorders
Dry eye
|
2.2%
1/46
|
|
Eye disorders
Left eye irritation
|
2.2%
1/46
|
|
Eye disorders
Chalazion
|
2.2%
1/46
|
|
Eye disorders
Eye pain
|
2.2%
1/46
|
|
Eye disorders
Floaters
|
4.3%
2/46
|
|
Eye disorders
Photophobia
|
2.2%
1/46
|
|
Eye disorders
Watering eyes
|
2.2%
1/46
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
3/46
|
|
Gastrointestinal disorders
Abdominal pain
|
30.4%
14/46
|
|
Gastrointestinal disorders
Ascites
|
8.7%
4/46
|
|
Gastrointestinal disorders
Bloating
|
4.3%
2/46
|
|
Gastrointestinal disorders
Constipation
|
13.0%
6/46
|
|
Gastrointestinal disorders
Diarrhea
|
78.3%
36/46
|
|
Gastrointestinal disorders
Dry Mouth
|
8.7%
4/46
|
|
Gastrointestinal disorders
Dyspepsia
|
10.9%
5/46
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
2.2%
1/46
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
2/46
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/46
|
|
Gastrointestinal disorders
Gastrointestinal disorders, Other, Specify
|
10.9%
5/46
|
|
Gastrointestinal disorders
Mucositis oral
|
6.5%
3/46
|
|
Gastrointestinal disorders
Nausea
|
54.3%
25/46
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.2%
1/46
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.2%
1/46
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.2%
1/46
|
|
Gastrointestinal disorders
Small intestine ulcer
|
2.2%
1/46
|
|
Gastrointestinal disorders
Vomiting
|
43.5%
20/46
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.2%
1/46
|
|
General disorders
Chills
|
13.0%
6/46
|
|
General disorders
Edema face
|
2.2%
1/46
|
|
General disorders
Edema limbs
|
19.6%
9/46
|
|
General disorders
Fatigue
|
56.5%
26/46
|
|
General disorders
Fever
|
15.2%
7/46
|
|
General disorders
Localized edema
|
4.3%
2/46
|
|
General disorders
Neck edema
|
2.2%
1/46
|
|
General disorders
Non-cardiac chest pain
|
4.3%
2/46
|
|
General disorders
Pain
|
4.3%
2/46
|
|
General disorders
Death NOS
|
8.7%
4/46
|
|
Infections and infestations
Abdominal infection
|
2.2%
1/46
|
|
Infections and infestations
Bladder infection
|
2.2%
1/46
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.2%
1/46
|
|
Infections and infestations
Lung infection
|
2.2%
1/46
|
|
Infections and infestations
Nail infection
|
2.2%
1/46
|
|
Infections and infestations
Paronychia
|
6.5%
3/46
|
|
Infections and infestations
Skin infection
|
4.3%
2/46
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Bruising
|
4.3%
2/46
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
2/46
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.2%
1/46
|
|
Investigations
Alanine aminotransferase increase
|
28.3%
13/46
|
|
Investigations
Alkaline phosphatase increased
|
28.3%
13/46
|
|
Investigations
Aspartate aminotransferase increased
|
45.7%
21/46
|
|
Investigations
Blood bilirubin increased
|
8.7%
4/46
|
|
Investigations
Creatinine increased
|
8.7%
4/46
|
|
Investigations
INR increased
|
6.5%
3/46
|
|
Investigations
Investigations - Other, specify
|
2.2%
1/46
|
|
Investigations
Lymphocyte count decreased
|
13.0%
6/46
|
|
Investigations
Neutrophil count decreased
|
10.9%
5/46
|
|
Investigations
Weight loss
|
10.9%
5/46
|
|
Investigations
White blood cell decreased
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
6/46
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.9%
5/46
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
19.6%
9/46
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
2/46
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
6/46
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
4/46
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
1/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.2%
1/46
|
|
Nervous system disorders
Dizziness
|
6.5%
3/46
|
|
Nervous system disorders
Dysgeusia
|
23.9%
11/46
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.2%
1/46
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
2/46
|
|
Nervous system disorders
Somnolence
|
2.2%
1/46
|
|
Nervous system disorders
Stroke
|
23.9%
11/46
|
|
Nervous system disorders
Tremor
|
2.2%
1/46
|
|
Psychiatric disorders
Confusion
|
4.3%
2/46
|
|
Psychiatric disorders
Delusions
|
2.2%
1/46
|
|
Psychiatric disorders
Insomnia
|
4.3%
2/46
|
|
Renal and urinary disorders
Acute kidney injury
|
8.7%
4/46
|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary frequency
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
4/46
|
|
Renal and urinary disorders
Epistaxis
|
4.3%
2/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.3%
2/46
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Body odor
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
37.0%
17/46
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.7%
10/46
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
60.9%
28/46
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
32.6%
15/46
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.3%
2/46
|
|
Vascular disorders
Flushing
|
2.2%
1/46
|
|
Vascular disorders
Hypertension
|
17.4%
8/46
|
|
Vascular disorders
Hypotension
|
2.2%
1/46
|
|
Vascular disorders
Thromboembolic event
|
6.5%
3/46
|
Additional Information
Dr. Andrew Ko, MD
university of california san francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60