Trial Outcomes & Findings for GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer (NCT NCT01553851)
NCT ID: NCT01553851
Last Updated: 2016-12-26
Results Overview
Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline and Day 15
Results posted on
2016-12-26
Participant Flow
Participant milestones
| Measure |
GSK1120212
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
GSK1120212
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
constipation
|
1
|
Baseline Characteristics
GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
GSK1120212
n=20 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Oral Cavity Sub-Site
Tongue
|
7 participants
n=5 Participants
|
|
Oral Cavity Sub-Site
Floor of Mouth
|
7 participants
n=5 Participants
|
|
Oral Cavity Sub-Site
Retromolar trigone
|
5 participants
n=5 Participants
|
|
Oral Cavity Sub-Site
Buccal
|
1 participants
n=5 Participants
|
|
Age, Customized
Median Age (years)
|
59.5 years
n=5 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Clinical Stage
Stage II
|
3 participants
n=5 Participants
|
|
Clinical Stage
Stage III
|
3 participants
n=5 Participants
|
|
Clinical Stage
Stage IV
|
14 participants
n=5 Participants
|
|
History of Smoking and/or Alcohol Abuse
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 15Population: Only15 of the 17 participants had sufficient pre- and post-treatment biopsies with sufficient tumor content to be evaluated for this biomarker assessment.
Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.
Outcome measures
| Measure |
GSK1120212
n=15 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.
Decrease in p-EPK1/2 expression
|
7 participants
|
|
Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.
Inverse relationship in p-EPK expression
|
2 participants
|
|
Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.
No change in p-EKP expression
|
3 participants
|
|
Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.
Increase in p-EKP expression
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline and Day 15Pre-post measure of CD44 expression using IHC.
Outcome measures
| Measure |
GSK1120212
n=15 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Number of Participants With Changes in TumorCell Surface CD44 Expression After Treatment With GSK1120212.
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 15Clinical Response was evaluted by quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.
Outcome measures
| Measure |
GSK1120212
n=17 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Percentage of Participants With Clinical Response Induced by GSK1120212, as Determined by Change in Tumor Size.
|
76 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 14, and Day 15Population: There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.
Peripheral blood - baseline and Day 14 Tumor - baseline and Day 15
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 14Population: Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)
Outcome measures
| Measure |
GSK1120212
n=13 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Percent Change in Maximum Standard Uptake Value in Oral Cavity Saqumous Cell Carcinoma (OCSCC) Using F18-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT).
|
-25 percentage change in SUVmax
Interval -52.0 to -6.0
|
SECONDARY outcome
Timeframe: 1st 4-6 week follow-up visitNumber of adverse events were monitored for 30 day following last dose of GSK1120212
Outcome measures
| Measure |
GSK1120212
n=20 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Safety of GSK1120212
Diarrhea (Grade 1-2)
|
3 Adverse events
|
|
Safety of GSK1120212
Neutrophil decrease (Grade 1-2)
|
1 Adverse events
|
|
Safety of GSK1120212
Thrombocytopenia(Grade 1-2)
|
1 Adverse events
|
|
Safety of GSK1120212
Colitis( Grade 3-4)
|
1 Adverse events
|
|
Safety of GSK1120212
Mucositis( Grade 3-4)
|
1 Adverse events
|
|
Safety of GSK1120212
Nausea (Grade 1-2)
|
2 Adverse events
|
|
Safety of GSK1120212
Doudenal Perforation (Grade 3-4)
|
1 Adverse events
|
|
Safety of GSK1120212
Stomach Cramps(Grade 1-2)
|
1 Adverse events
|
|
Safety of GSK1120212
Lung Infection (Grade 3-4)
|
1 Adverse events
|
|
Safety of GSK1120212
Rash, acneiform (Grade 1-2)
|
9 Adverse events
|
|
Safety of GSK1120212
Pruritis (Grade 1-2)
|
1 Adverse events
|
|
Safety of GSK1120212
Fatigue(Grade 1-2)
|
2 Adverse events
|
|
Safety of GSK1120212
Fever (Grade 1-2)
|
1 Adverse events
|
|
Safety of GSK1120212
Alkaline Phosphatase (Grade 1-2)
|
3 Adverse events
|
|
Safety of GSK1120212
AST (Grade 1-2)
|
4 Adverse events
|
|
Safety of GSK1120212
ALT (Grade 1-2)
|
2 Adverse events
|
|
Safety of GSK1120212
Blurry Vision (Grade 1-2)
|
1 Adverse events
|
|
Safety of GSK1120212
Hypotension (Grade 1-2)
|
1 Adverse events
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.
Outcome measures
| Measure |
GSK1120212
n=17 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Percent Change in Tumor Size Area
|
-46 percent change in tumor size area
Interval -74.0 to -14.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)
Intratumarol metabolic changes were evaluated by changes in in SUVmax in the primary tumor; quantitative analysis SUVmax with the primary tumor site was determined within a volume of interest around the tumor using a Siemens eSoft workstation.
Outcome measures
| Measure |
GSK1120212
n=13 Participants
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Percent of Participants With Metabolic Changes in OCSCC Using FDG-PET/CT Imaging.
|
85 percentage of participants
|
Adverse Events
GSK1120212
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1120212
n=20 participants at risk
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Blood Bilirubin increased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Neutrophil count increased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
White cell count decreased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Colitis
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Mucositis Oral
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Vomitting
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Duodenal Perforation
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Infections and infestations
Infections and infestations -Other: Skin Infection
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Infections and infestations
Shingles
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Infections and infestations
Lung Infection
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
Other adverse events
| Measure |
GSK1120212
n=20 participants at risk
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
45.0%
9/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Cardiac disorders
Hypertension
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Eye disorders
Blurred vision
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Mucositis Oral
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Oral pain
|
30.0%
6/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Small intestines obstruction
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Gastrointestinal disorders
Vomitting
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
General disorders
Chills
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
General disorders
Edema limbs
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
General disorders
Fatigue
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
General disorders
Fever
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
General disorders
Localized Edema
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Infections and infestations
Papulopustular rash
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Infections and infestations
Infections and infestation-Other: Skin infection
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleed
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Alkaline Phosphatase increased
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
5/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Creatinine increased
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
INR increased
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Platelet count decreased
|
25.0%
5/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Investigations
Lymphocyte decreased
|
20.0%
4/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
35.0%
7/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
6/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
6/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Nervous system disorders
Dysarthria
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
2/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
40.0%
8/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • Adverse events were collected for 4-6 weeks.
AE grade 3 or higher will be followed for 3-6 months and considered at least possibly related
|
Additional Information
Dr. Douglas Atkins
Washington University School of Medicine
Phone: 314-747-8475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place