Trial Outcomes & Findings for Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer (NCT NCT01875250)
NCT ID: NCT01875250
Last Updated: 2020-09-16
Results Overview
Growth rate was measured using the growth rate equation -f(t) = exp (-d\*t) + exp (g\*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
7 months
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Arm A - Enzalutamide for 3 Months
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A - Enzalutamide for 3 Months
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A - Enzalutamide for 3 Months
n=19 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
n=19 Participants
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
66.07 years
STANDARD_DEVIATION 5.29 • n=7 Participants
|
65.88 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 monthsGrowth rate was measured using the growth rate equation -f(t) = exp (-d\*t) + exp (g\*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics.
Outcome measures
| Measure |
Arm A - Enzalutamide for 3 Months
n=19 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
n=19 Participants
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Tumor Growth Rate
|
0.031 unitless
|
0.030 unitless
|
SECONDARY outcome
Timeframe: 30 Days After the Start of Course 1 and Course 2 of EnzalutamidePopulation: It was pre-specified to combine analysis for Arms of growth factors.
VEGF was measured by the enzyme-linked immunosorbent assay (ELISA) assay. The lower limit of quantitation of assay was 9.0 pg/ml.
Outcome measures
| Measure |
Arm A - Enzalutamide for 3 Months
n=36 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide
Course 1
|
192 pg/ml
Standard Deviation 82
|
—
|
|
Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide
Course 2
|
165.04 pg/ml
Standard Deviation 82.38
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: It was pre-specified to combine analysis for testosterone. In addition, data was not analyzed beyond Course 1 because it was not part of the initial statistical plan.
Normal testosterone is 270-1070 nd/dL.
Outcome measures
| Measure |
Arm A - Enzalutamide for 3 Months
n=36 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Median Testosterone After 84 Days of Enzalutamide
|
834 ng/dl
Interval 308.0 to 1579.0
|
—
|
SECONDARY outcome
Timeframe: 84 daysMedian PSA change would be considered optimal.
Outcome measures
| Measure |
Arm A - Enzalutamide for 3 Months
n=19 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
n=19 Participants
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1
|
-99 Percent change
Interval -84.0 to -99.0
|
-99 Percent change
Interval -87.0 to -99.0
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm A - Enzalutamide for 3 Months
n=19 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
n=19 Participants
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: up to 41 monthsPopulation: It was pre-specified to combine analysis for Arms of PSA Recovery time.
PSA recovery is defined as the return above baseline PSA in participants with normal testosterone and non-metastatic, castration sensitive prostate cancer.
Outcome measures
| Measure |
Arm A - Enzalutamide for 3 Months
n=36 Participants
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide
Course 1
|
224 Days
Interval 84.0 to 1246.0
|
—
|
|
Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide
Course 2
|
189 Days
Interval 78.0 to 400.0
|
—
|
Adverse Events
Arm A - Enzalutamide for 3 Months
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Enzalutamide for 3 Months
n=19 participants at risk
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
n=19 participants at risk
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
Other adverse events
| Measure |
Arm A - Enzalutamide for 3 Months
n=19 participants at risk
Enzalutamide for 3 months
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
Arm B - Enzalutamide for 3 Months + PSA-TRICOM
n=19 participants at risk
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21
PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
Enzalutamide (Xtandi): An androgen receptor inhibitor.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Alanine aminotransferase increased
|
26.3%
5/19 • Number of events 9 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
26.3%
5/19 • Number of events 8 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Blood and lymphatic system disorders
Anemia
|
26.3%
5/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
42.1%
8/19 • Number of events 11 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
21.1%
4/19 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Immune system disorders
Autoimmune disorder
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.1%
4/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
42.1%
8/19 • Number of events 12 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Eye disorders
Blurred vision
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Reproductive system and breast disorders
Breast atrophy
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Reproductive system and breast disorders
Breast pain
|
78.9%
15/19 • Number of events 19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
84.2%
16/19 • Number of events 21 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Bronchial infection
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
CPK increased
|
21.1%
4/19 • Number of events 10 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
21.1%
4/19 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Eye disorders
Cataract
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Chills
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Cholesterol high
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
26.3%
5/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
4/19 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Creatinine increased
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Diarrhea
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
26.3%
5/19 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Dizziness
|
26.3%
5/19 • Number of events 10 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
26.3%
5/19 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Edema limbs
|
26.3%
5/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Eye disorders
Eye disorders - Other, Diplopia Lightheadedness intermittent
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Eye disorders
Eye disorders - Other, Tearfullness
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Eye infection
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Fatigue
|
84.2%
16/19 • Number of events 26 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
84.2%
16/19 • Number of events 28 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Fever
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Eye disorders
Flashing lights
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Flatulence
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Flu like symptoms
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
31.6%
6/19 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Damaged broken tooth
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Reflux
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Gum infection
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Reproductive system and breast disorders
Gynecomastia
|
47.4%
9/19 • Number of events 13 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
36.8%
7/19 • Number of events 8 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
31.6%
6/19 • Number of events 13 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Hematuria
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Vascular disorders
Hot flashes
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.4%
9/19 • Number of events 26 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
42.1%
8/19 • Number of events 14 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
21.1%
4/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Vascular disorders
Hypertension
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
47.4%
9/19 • Number of events 26 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
36.8%
7/19 • Number of events 24 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Diverticulitis-received 2 antibiotics
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Flu 2-3 weeks ago,
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, No antibiotics
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, URI and rash
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, URI-head cold, uses Dayquil
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, UTI
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Viral infection
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Wound infection
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Cold
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Cold- OTC meds
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Erythema
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, Fungal infection-Terbinafine
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Infections and infestations - Other, URI- no antibiotics
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
94.7%
18/19 • Number of events 70 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Lethargy
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
21.1%
4/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Reproductive system and breast disorders
Libido decreased
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Lip infection
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Lymphocyte count decreased
|
36.8%
7/19 • Number of events 15 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
42.1%
8/19 • Number of events 22 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Memory impairment
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
36.8%
7/19 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Nausea
|
36.8%
7/19 • Number of events 8 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
21.1%
4/19 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Neutrophil count decreased
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Reproductive system and breast disorders
Nipple deformity
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
General disorders
Pain
|
21.1%
4/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
26.3%
5/19 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Paresthesia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Platelet count decreased
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
21.1%
4/19 • Number of events 9 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Rhinitis infective
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Dry skin
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Fullness B/L in temporal area-not painful
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Pre cancerous lesion
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Sores on feet
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Abraasion
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Allergic reaction
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Callus
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Cold sore
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Stomach pain
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Infections and infestations
Upper respiratory infection
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
26.3%
5/19 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Urinary frequency
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
31.6%
6/19 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Urinary tract pain
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Renal and urinary disorders
Urine discoloration
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/19 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Weight gain
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
Weight loss
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
|
Investigations
White blood cell decreased
|
26.3%
5/19 • Number of events 9 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
42.1%
8/19 • Number of events 12 • Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place