Trial Outcomes & Findings for Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma (NCT NCT01979523)
NCT ID: NCT01979523
Last Updated: 2026-04-13
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
from randomization to the earlier date of objective disease progression or death
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Arm A (Trametinib)
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
Arm B (Trametinib, Akt Inhibitor GSK2141795)
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Trametinib)
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
Arm B (Trametinib, Akt Inhibitor GSK2141795)
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Arm A (Trametinib)
n=21 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=21 Participants
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=193 Participants
|
59.6 years
n=193 Participants
|
59.3 years
n=386 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
19 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
23 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=193 Participants
|
21 Participants
n=193 Participants
|
42 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=193 Participants
|
21 Participants
n=193 Participants
|
41 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=193 Participants
|
21 participants
n=193 Participants
|
42 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: from randomization to the earlier date of objective disease progression or deathPopulation: This assessment corresponds to the participants' initial treatment assignment.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=21 Participants
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Arm A (Trametinib)
n=20 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
|---|---|---|
|
Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST
|
15.6 weeks
Interval 3.9 to 137.0
|
16.6 weeks
Interval 3.3 to 43.7
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 monthsPopulation: This assessment corresponds to the participants' initial treatment assignment.
Graded according to the National Cancer Institute CTCAE v4.0. Please see AE/SAE Section for specifics.
Outcome measures
| Measure |
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=21 Participants
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Arm A (Trametinib)
n=21 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
|---|---|---|
|
Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent
|
21 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: This assessment corresponds to the participants' initial treatment assignment.
OS curves will be generated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=21 Participants
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Arm A (Trametinib)
n=20 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
|---|---|---|
|
Overall Survival (OS) Per RECIST Criteria
|
88 weeks
Interval 4.1 to 152.0
|
69 weeks
Interval 3.3 to 139.0
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 monthsPopulation: This assessment corresponds to the participants' initial treatment assignment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Outcome measures
| Measure |
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=18 Participants
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Arm A (Trametinib)
n=19 Participants
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
|---|---|---|
|
Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria
Partial Response
|
1 participants
|
2 participants
|
|
Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria
Progression of Disease
|
4 participants
|
8 participants
|
|
Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria
Stable Disease
|
13 participants
|
9 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 4 weeks from last treatmentPopulation: The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 4 weeks from last treatmentPopulation: The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set.
Association between suppression and response to treatment will be assessed using Fisher's exact test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks from last treatmentPopulation: Data were not analyzed due to lack of funding.
The numeric data will be summarized by clinical response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks from last treatmentPopulation: Analysis across the sample set unable to be completed due to patient-specific issues (participants skipped biopsy for safety, insufficient cores for extra DNA extraction)
Clinical response will be associated with Gnaq/11 mutational status using Wilcoxon rank sum test.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Trametinib)
Serious events: 8 serious events
Other events: 20 other events
Deaths: 5 deaths
Arm B (Trametinib, Akt Inhibitor GSK2141795)
Serious events: 12 serious events
Other events: 21 other events
Deaths: 13 deaths
Crossover Arm
Serious events: 11 serious events
Other events: 11 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm A (Trametinib)
n=20 participants at risk
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=21 participants at risk
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Crossover Arm
n=11 participants at risk
Participants had progression of disease on Arm A and were then treated on Arm B.
|
|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Edema face
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, specify
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
42.9%
9/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
14.3%
3/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Fever
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
18.2%
2/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Nervous system disorders
Stroke
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
81.8%
9/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
Other adverse events
| Measure |
Arm A (Trametinib)
n=20 participants at risk
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
|
Arm B (Trametinib, Akt Inhibitor GSK2141795)
n=21 participants at risk
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Trametinib: Given PO
Uprosertib: Given PO
|
Crossover Arm
n=11 participants at risk
Participants had progression of disease on Arm A and were then treated on Arm B.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
23.8%
5/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
45.5%
5/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Alkaline phosphatase increased
|
15.0%
3/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
28.6%
6/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
18.2%
2/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
27.3%
3/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
4/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
33.3%
7/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Blood bilirubin increased
|
15.0%
3/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
14.3%
3/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Eye disorders
Blurred vision
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Bronchial infection
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
CPK increased
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Chills
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Cholesterol high
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
54.5%
6/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Edema limbs
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
18.2%
2/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Ejection fraction decreased
|
20.0%
4/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Fatigue
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
28.6%
6/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
54.5%
6/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Hematoma
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
14.3%
3/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
36.4%
4/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Hypertension
|
20.0%
4/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
47.6%
10/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
18.2%
2/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
4/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
14.3%
3/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
4/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
INR increased
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Localized edema
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
45.5%
5/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other, spec
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
4/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Vulval infection
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
19.0%
4/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
54.5%
6/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
15.0%
3/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Paronychia
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Platelet count decreased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
63.6%
7/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
45.0%
9/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
19.0%
4/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
54.5%
6/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Skin infection
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Superficial thrombophlebitis
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Vascular disorders
Thromboembolic event
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
36.4%
4/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
45.5%
5/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Creatinine increased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
General disorders
Edema trunk
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Lip infection
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Nail infection
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.5%
2/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
4.8%
1/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
Weight loss
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
36.4%
4/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Investigations
WBC Decreased
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
18.2%
2/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/20 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
0.00%
0/21 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
9.1%
1/11 • From date of randomization until the date of death from any cause or 4 weeks from removal of the study, whichever came first, assessed up to 12 months
AE's and SAE's for Arm A, Arm B, and the crossover group were collected.
|
Additional Information
Dr. Alexander Shoushtari
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60