Trial Outcomes & Findings for Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer (NCT NCT02649855)
NCT ID: NCT02649855
Last Updated: 2026-04-29
Results Overview
Antigen spreading as measured by antigen spread score. The antigen spreading score denotes the presence of a T-cell (cluster of differentiation(CD8)+ and/or cluster of differentiation 4(CD4+) immune response against 2 tumor associated antigens that were not targeted by PROSTVAC:Mucin 1(MUC-1) \& carcinoembryonic antigen(CEA). Antigen-specific T-cell responses were determined using intracellular cytokine staining of 4 established markers (Lysosome-associated membrane proteins h-LAMP1, interferon gamma, interleukin-2\& tumor necrosis factor) in both CD4+\& CD8+T-cells, giving a total of 8 measures of activation per antigen. Numbers of activation markers per antigen were totaled \& multiplied by 1.5 to give higher weighting to T-cell responses to antigens that were not targeted by PROSTVAC;\& the scores for both MUC-1 \& CEA were totaled per participant, with a possible range of 0-24 (0 is a negative result whereas 1.5-24 are positive results). The higher level of response, the better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
After 19 Weeks
Results posted on
2026-04-29
Participant Flow
Participant milestones
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
28
|
|
Overall Study
COMPLETED
|
19
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
Reasons for withdrawal
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Overall Study
Refused further treatment
|
2
|
1
|
1
|
|
Overall Study
Withdrew consent
|
0
|
1
|
0
|
|
Overall Study
Switched to alternative treatment
|
0
|
1
|
1
|
|
Overall Study
Principal investigator discretion
|
0
|
1
|
1
|
|
Overall Study
No treatment, per protocol
|
1
|
0
|
0
|
|
Overall Study
Initiate new treatment
|
1
|
0
|
0
|
Baseline Characteristics
Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
n=23 Participants
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=23 Participants
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=28 Participants
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=73 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=9 Participants
|
13 Participants
n=24 Participants
|
17 Participants
n=23 Participants
|
42 Participants
n=73 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
11 Participants
n=23 Participants
|
31 Participants
n=73 Participants
|
|
Age, Continuous
|
66.03 years
STANDARD_DEVIATION 8.63 • n=9 Participants
|
59.8 years
STANDARD_DEVIATION 14.84 • n=24 Participants
|
62.81 years
STANDARD_DEVIATION 8.46 • n=23 Participants
|
62.87 years
STANDARD_DEVIATION 11.02 • n=73 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=9 Participants
|
23 Participants
n=24 Participants
|
28 Participants
n=23 Participants
|
74 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=9 Participants
|
23 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
66 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=73 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=23 Participants
|
15 Participants
n=73 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=9 Participants
|
17 Participants
n=24 Participants
|
18 Participants
n=23 Participants
|
53 Participants
n=73 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=73 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=9 Participants
|
23 participants
n=24 Participants
|
28 participants
n=23 Participants
|
74 participants
n=73 Participants
|
PRIMARY outcome
Timeframe: After 19 WeeksPopulation: 46/74 participants are evaluable for this outcome measure.
Antigen spreading as measured by antigen spread score. The antigen spreading score denotes the presence of a T-cell (cluster of differentiation(CD8)+ and/or cluster of differentiation 4(CD4+) immune response against 2 tumor associated antigens that were not targeted by PROSTVAC:Mucin 1(MUC-1) \& carcinoembryonic antigen(CEA). Antigen-specific T-cell responses were determined using intracellular cytokine staining of 4 established markers (Lysosome-associated membrane proteins h-LAMP1, interferon gamma, interleukin-2\& tumor necrosis factor) in both CD4+\& CD8+T-cells, giving a total of 8 measures of activation per antigen. Numbers of activation markers per antigen were totaled \& multiplied by 1.5 to give higher weighting to T-cell responses to antigens that were not targeted by PROSTVAC;\& the scores for both MUC-1 \& CEA were totaled per participant, with a possible range of 0-24 (0 is a negative result whereas 1.5-24 are positive results). The higher level of response, the better outcome.
Outcome measures
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
n=16 Participants
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=12 Participants
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=18 Participants
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks
|
4.31 Score on a scale
Standard Deviation 1.31
|
5.63 Score on a scale
Standard Deviation 1.63
|
4.00 Score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 39 weeks and 1 yearPopulation: 46/74 participants(pts) are evaluable for this outcome measure. Analysis was not performed for Arm B at 1yr because the intent was to compare treatments when they were completed to each other in terms of immune responses. Since no further treatments were given in Arm B after the 39th week, a second analysis was not required to assess immune responses. Pts in Arms A\&C may have continued treatment beyond 39 wks since they were sequential. 1yr mark was designed to capture treatments beyond wk 39.
Response score denotes the presence of a T-cell (cluster of differentiation 8(CD8+) and/or cluster of differentiation 4(CD4+) response against 3 tumor associated antigens: prostate-specific antigen(PSA), mucin 1(MUC-1) and carcinoembryonic antigen(CEA). Antigen-specific T-cell immune responses were determined using intracellular cytokine staining of 4 established markers (Lysosome-associated membrane proteins h-LAMP1, interferon gamma, interleukin-2\& tumor necrosis factor in both CD4+ \& CD8+T-cells, a total of 8 measures of activation per antigen. The number of activation markers for PSA were totaled for a maximum score of 8. Numbers of activation markers for MUC-1 \& CEA were totaled \& multiplied by 1.5 to give higher weighting to T-cell responses to antigens that were not targeted by PROSTVAC. The scores for PSA, MUC-1 \& CEA were totaled per participant, with a possible range of 0-32 (0 is a negative result whereas 1-32 are positive results). Higher level of response, better outcome.
Outcome measures
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
n=16 Participants
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=12 Participants
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=18 Participants
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Antigen Specific T-cell Immune Composite Response Scores Between All Arms at 39 Weeks and 1 Year
39 Weeks
|
7.03 Score on a scale
Standard Deviation 1.88
|
7.29 Score on a scale
Standard Deviation 1.83
|
6.91 Score on a scale
Standard Deviation 2.05
|
|
Antigen Specific T-cell Immune Composite Response Scores Between All Arms at 39 Weeks and 1 Year
1 Year
|
5.25 Score on a scale
Standard Deviation 1.48
|
—
|
6.44 Score on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 39 weeks and 1 yearPopulation: 46/74 participants(pts) are evaluable for this outcome measure. Analysis was not performed for Arm B at 1yr because the intent was to compare treatments when they were completed to each other in terms of immune responses. Since no further treatments were given in Arm B after the 39th week, a second analysis was not required to assess immune responses. Pts in Arms A\&C may have continued treatment beyond 39 wks since they were sequential. 1yr mark was designed to capture treatments beyond wk 39.
PSA-specific immune responses T-cell responses were assessed using nonparametric methods. The value denotes the number of participants with T-cell immune responses towards PSA. The higher level of response, the better outcome.
Outcome measures
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
n=16 Participants
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=12 Participants
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=18 Participants
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Number of Participants With T-cell Response to Prostate-specific Antigen (PSA)
39 Weeks
|
7 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With T-cell Response to Prostate-specific Antigen (PSA)
1 Year
|
5 Participants
|
—
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.Here is the number of participants with serious and/or 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/Sequential Docetaxel Followed by PROSTVAC
n=23 Participants
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=23 Participants
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=28 Participants
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
22 Participants
|
20 Participants
|
27 Participants
|
Adverse Events
Arm A/Sequential Docetaxel Followed by PROSTVAC
Serious events: 1 serious events
Other events: 22 other events
Deaths: 11 deaths
Arm B/ Combined Docetaxel With PROSTVAC
Serious events: 1 serious events
Other events: 20 other events
Deaths: 11 deaths
Arm C/ PROSTVAC Prior to Docetaxel
Serious events: 3 serious events
Other events: 27 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
n=23 participants at risk
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=23 participants at risk
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=28 participants at risk
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Edema limbs
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Flu like symptoms
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
Other adverse events
| Measure |
Arm A/Sequential Docetaxel Followed by PROSTVAC
n=23 participants at risk
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm B/ Combined Docetaxel With PROSTVAC
n=23 participants at risk
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
Arm C/ PROSTVAC Prior to Docetaxel
n=28 participants at risk
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
PROSTVAC-V: It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
PROSTVAC-F: It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
Docetaxel: It is commercially available. It will be administered at 75 mg/m(2) intravenously.
|
|---|---|---|---|
|
General disorders
Chills
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Edema face
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Edema limbs
|
26.1%
6/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
34.8%
8/23 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
53.6%
15/28 • Number of events 19 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Fatigue
|
30.4%
7/23 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
47.8%
11/23 • Number of events 12 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
57.1%
16/28 • Number of events 19 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Obesity
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
1/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.5%
10/23 • Number of events 11 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
26.1%
6/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
57.1%
16/28 • Number of events 17 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Blurred vision
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
25.0%
7/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Creatinine increased
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Cystitis noninfective
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Diarrhea
|
26.1%
6/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
32.1%
9/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Dry eye
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Dry mouth
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.4%
7/23 • Number of events 7 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Dysgeusia
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
30.4%
7/23 • Number of events 7 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
28.6%
8/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Eye disorders - Other, Eye tearing
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Eye disorders - Other, L retina abnormality
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Fever
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Flashing lights
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Floaters
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Flu like symptoms
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.9%
5/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Broken tooth
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Vascular disorders
Hot flashes
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
57.1%
16/28 • Number of events 18 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Infusion related reaction
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
21.7%
5/23 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
14.3%
4/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Injection site reaction
|
47.8%
11/23 • Number of events 14 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
60.9%
14/23 • Number of events 20 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
67.9%
19/28 • Number of events 34 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
25.0%
7/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Reproductive system and breast disorders
Libido decreased
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Infections and infestations
Lip infection
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Lipase increased
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
21.4%
6/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Malaise
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
14.3%
4/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Discolored lips- intermittent
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, sprained right ankle
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
14.3%
4/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
34.8%
8/23 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
39.3%
11/28 • Number of events 12 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
28.6%
8/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, melanoma
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Nervous system disorders - Other, Neuropathy
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Nervous system disorders - Other, numbness - right thigh
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Numbness
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Pain
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
53.6%
15/28 • Number of events 22 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
General disorders
Pain in extremity
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Paresthesia
|
34.8%
8/23 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
21.7%
5/23 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Reproductive system and breast disorders
Penile infection
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.7%
2/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
39.3%
11/28 • Number of events 16 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Platelet count decreased
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
14.3%
4/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
17.9%
5/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Shortness of breath
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Serum amylase increased
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Abrasions
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Blister
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Contact dermatitis
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Dermatitis with rash on bilateral hands
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, skin-actinic keratosis
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Infections and infestations
Skin infection
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Vascular disorders
Thromboembolic event
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Nervous system disorders
Tremor
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Infections and infestations
Upper respiratory infection
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
10.7%
3/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
13.0%
3/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Eye disorders
Watering eyes
|
21.7%
5/23 • Number of events 5 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
7.1%
2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Weight gain
|
8.7%
2/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
Weight loss
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/23 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
3.6%
1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
|
Investigations
White blood cell decreased
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
0.00%
0/28 • Date treatment consent signed to date off study, approximately 70 months and 4 days for Arm A, 38 months and 28 days for Arm B, and 43 months and 29 days for Arm C.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place