Trial Outcomes & Findings for Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (NCT NCT03493945)
NCT ID: NCT03493945
Last Updated: 2025-09-30
Results Overview
Objective clinical response and/or prostate-specific antigen (PSA) decline of \>=30% sustained for a minimum of 21 days. Any of these is considered 'clinical benefit.' Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
From enrollment up to 49 weeks
Results posted on
2025-09-30
Participant Flow
Participant milestones
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1
Phase I Dose Escalation, Cohort 1, Arm 1.1, Dose Level 1 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 1 =10mcg/kg, M7824 Dose Level 1 =1200mg
|
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated
Phase I Dose Escalation, Cohort 1 Participants with any solid tumor M7824 + N-803 (accrual closed)
|
|---|---|---|---|---|---|---|---|
|
Phase I Dose Escalation
STARTED
|
0
|
0
|
0
|
0
|
4
|
10
|
1
|
|
Phase I Dose Escalation
COMPLETED
|
0
|
0
|
0
|
0
|
4
|
9
|
0
|
|
Phase I Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Phase II Dose Expansion
STARTED
|
13
|
13
|
12
|
6
|
4
|
9
|
0
|
|
Phase II Dose Expansion
Follow up Period Completed
|
7
|
11
|
7
|
6
|
2
|
5
|
0
|
|
Phase II Dose Expansion
Disease Progression on Study
|
7
|
8
|
9
|
1
|
1
|
2
|
0
|
|
Phase II Dose Expansion
COMPLETED
|
10
|
12
|
11
|
6
|
4
|
9
|
0
|
|
Phase II Dose Expansion
NOT COMPLETED
|
3
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1
Phase I Dose Escalation, Cohort 1, Arm 1.1, Dose Level 1 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 1 =10mcg/kg, M7824 Dose Level 1 =1200mg
|
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated
Phase I Dose Escalation, Cohort 1 Participants with any solid tumor M7824 + N-803 (accrual closed)
|
|---|---|---|---|---|---|---|---|
|
Phase I Dose Escalation
Ineligible
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase I Dose Escalation
New therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase II Dose Expansion
Refused further treatment
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Phase II Dose Expansion
Switched to alternative therapy
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
Baseline characteristics by cohort
| Measure |
Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1
n=4 Participants
Phase I Dose Escalation, Cohort 1, Arm 1.1, Dose Level 1 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 1 =10mcg/kg, M7824 Dose Level 1 =1200mg
|
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2
n=10 Participants
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated
n=1 Participants
Phase I Dose Escalation, Cohort 1 Participants with any solid tumor M7824 + N-803 (accrual closed)
|
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 Participants
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
|
Age, Continuous
|
54.23 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
52.34 years
STANDARD_DEVIATION 12.05 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
67.81 years
STANDARD_DEVIATION 9.23 • n=4 Participants
|
65.69 years
STANDARD_DEVIATION 6.81 • n=21 Participants
|
66.57 years
STANDARD_DEVIATION 6.97 • n=8 Participants
|
75.47 years
STANDARD_DEVIATION 8.44 • n=8 Participants
|
64.03 years
STANDARD_DEVIATION 11.19 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
50 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
1 participants
n=5 Participants
|
13 participants
n=4 Participants
|
13 participants
n=21 Participants
|
12 participants
n=8 Participants
|
6 participants
n=8 Participants
|
59 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to 49 weeksPopulation: 43/59 participants were analyzed because 14 were not applicable for this endpoint per protocol, 1 was ineligible and 1 was not able to be assessed for this endpoint because participant withdrew from the study before having efficacy assessments.
Objective clinical response and/or prostate-specific antigen (PSA) decline of \>=30% sustained for a minimum of 21 days. Any of these is considered 'clinical benefit.' Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
Outcome measures
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=24 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval
|
.076 Proportion of participants
Interval 0.0081 to 0.268
|
0.292 Proportion of participants
Interval 0.17 to 0.442
|
0 Proportion of participants
Interval 0.0 to 0.319
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From enrollment up to 49 weeksPopulation: 43/59 participants were analyzed because 14 were not applicable for this endpoint per protocol, 1 was ineligible, and 1 was not able to be assessed for this endpoint because participant withdrew from the study before having efficacy assessments.
Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
Outcome measures
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=24 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval
Complete Response
|
0 Proportion of participants
Interval 0.0 to 0.708
|
0 Proportion of participants
Interval 0.0 to 0.459
|
0 Proportion of participants
Interval 0.0 to 0.975
|
—
|
—
|
—
|
|
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval
Partial Response
|
0 Proportion of participants
Interval 0.0 to 0.708
|
0.33 Proportion of participants
Interval 0.0433 to 0.777
|
0 Proportion of participants
Interval 0.0 to 0.975
|
—
|
—
|
—
|
|
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval
Stable Disease
|
0.33 Proportion of participants
Interval 0.0084 to 0.906
|
0 Proportion of participants
Interval 0.0 to 0.459
|
0 Proportion of participants
Interval 0.0 to 0.975
|
—
|
—
|
—
|
|
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval
Progressive Disease
|
0.67 Proportion of participants
Interval 0.0943 to 0.9916
|
0.67 Proportion of participants
Interval 0.223 to 0.957
|
1 Proportion of participants
Interval 0.025 to 1.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 21 days of the start of treatmentPopulation: 58/59 participants were analyzed because 1 was ineligible.
A DLT is defined as any of the following adverse events (AE) possibly related to study drugs that occur within 21 days of the start of treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 3 is moderate. Grade 4 is life-threatening, and Grade 5 is death related to AE. A DLT is any grade ≥ 4 hematologic toxicity or grade 3 thrombocytopenia with associated bleeding; any grade ≥ 3 non-hematologic toxicity, except for any of the following: transient (≤ 48 hour) grade 3 fatigue, local reactions, flu-like symptoms, fever, headache, or nausea, emesis, and diarrhea; or CTCAE Grade 3 skin toxicity lasting less than five days. A non-serious AE is any untoward medical occurrence. A serious AE 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, or congenital anomaly/birth defect.
Outcome measures
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=4 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=10 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 Participants
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Phase I/II: Number of Participants With Grades 3, 4, and/or 5 Serious and/or Non-serious Dose-limiting Toxicities (DLT)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase I/II: Number of Participants With Grades 3, 4, and/or 5 Serious and/or Non-serious Dose-limiting Toxicities (DLT)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase I/II: Number of Participants With Grades 3, 4, and/or 5 Serious and/or Non-serious Dose-limiting Toxicities (DLT)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: 43/59 participants were analyzed because 14 were not applicable for this endpoint per protocol, 1 was ineligible, and 1 was not able to be assessed for this endpoint because participant withdrew from the study before having efficacy assessments.
6-month progression free survival was measured from the on-study date until progression or death without progression in participants and reported with a 95% confidence interval. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=24 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
6-month Progression Free Survival (PFS) Probability
|
0.354 proportion probability
Interval 0.152 to 0.822
|
0.348 proportion probability
Interval 0.196 to 0.617
|
NA proportion probability
Since no participant was followed past 6 months for progression in arm 2.3, the 6-month PFS confidence interval (CI) is not estimable as well.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks dose-limiting toxicity (DLT) periodNumber of participants with grades 1, 2, 3, and 4 non-serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803).
Outcome measures
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=4 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=10 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 Participants
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anorexia possibly related to M7824
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Pancreatitis probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Dry mouth possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Infusion related reaction probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Proctitis probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Endocrine disorders - Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Eye disorders possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Epistaxis possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Pruritus probably related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Abdominal pain possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fever possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 General disorders and administration site conditions-Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Abdominal pain possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Aspartate aminotransferase increased possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Endocrine disorders - Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Malaise possibly related to M7824
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Mucositis oral possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Nausea possibly related to M7824
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular possibly related to M7824
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Sinus tachycardia possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Thyroid stimulating hormone possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Alanine aminotransferase increased probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Alkaline phosphatase increased probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Aspartate aminotransferase increased probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Cystitis noninfective probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dry skin probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Endocrine disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Enterocolitis probably related to M7824
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Eosinophilia probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Gastrointestinal disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 General disorders and administration site conditions probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Gingival pain probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperthyroidism probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypotension probably related to M7824
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Metabolism and nutrition disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Neoplasms benign, malignant and unspecified incl cysts and polyps probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Oral hemorrhage probably related to M7824
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash acneiform probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular probably related to M7824
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Serum amylase probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Thyroid stimulating hormone increased probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Bullous dermatitis definitely related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperkeratosis definitely related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypothyroidism definitely related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Infusion related reaction definitely related to M7824
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction definitely related to M7824
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Paresthesia definitely related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Periorbital edema probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders - Other specify definitely related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Alanine aminotransferase increased possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anal hemorrhage possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anemia possibly related to M7824
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Diarrhea possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hematuria possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hypotension possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Joint range of motion decreased possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lipase increased possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lymphocyte count decreased possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Mucositis oral possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Musculoskeletal and connective tissue disorder Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Nausea possibly related to M7824
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pain possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Proteinuria possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pruritus possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Skin and subcutaneous tissue disorders Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Small intestine ulcer possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Vomiting possibly related to M7824
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anemia probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Bullous dermatitis probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Dry mouth probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Endocrine disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Eye disorders probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hyperthyroidism probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hypothyroidism probably related to M7824
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Infusion related reaction probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lipase increased probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Proctitis probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Serum amylase probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Skin and subcutaneous tissue disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Urticaria probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Arthritis definitely related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Infusion related reaction definitely related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pain possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pruritus definitely related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Skin and subcutaneous tissue disorders Other specify definitely related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Anemia possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Blood and lymphatic system disorders Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Gastrointestinal disorders Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Rash maculopapular possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Eosinophilia probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Lipase increased probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Alanine aminotransferase increased possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Aspartate aminotransferase increased possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Proteinuria possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dizziness possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dry skin possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Eye disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemolysis possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperhidrosis possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Insomnia possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Malaise possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Mucositis oral possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Myalgia possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Vertigo possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Weight loss possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anal hemorrhage possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Bloating possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Blood and lymphatic system disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Diarrhea possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dry mouth possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flatulence possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flu-like symptoms possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemorrhoidal hemorrhage possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hoarseness possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypothyroidism possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Sinus tachycardia possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Vomiting possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pain possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Thyroid stimulating hormone possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Alanine aminotransferase increased probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Alkaline phosphatase increased probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Aspartate aminotransferase increased probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Eosinophilia probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Gastrointestinal disorders Other specify probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypothyroidism probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Lipase increased probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Metabolism and nutrition disorders Other specify probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Periorbital edema probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Serum amylase probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Cystitis noninfective probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dry skin probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Endocrine disorders Other specify probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hematuria probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Oral hemorrhage probably related to research
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Gastrointestinal disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Abdominal pain possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Epistaxis possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anorexia possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Diarrhea probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 General disorders& administration site conditions Other specify probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperhidrosis probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Myalgia probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Neutrophil count decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Neoplasms benign, malignant and unspecified Other specify probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash acneiform probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Vomiting probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Malaise probably related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Enterocolitis probably related to research
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anorexia probably related to research
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Headache probably related to research
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Nausea probably related to research
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue possibly related to research
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills possibly related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Generalized muscle weakness possibly related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dizziness probably related to research
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction probably related to research
|
1 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypothyroidism definitely related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Paresthesia definitely related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperkeratosis definitely related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemolysis definitely related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever definitely related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Nausea possibly related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Headache possibly related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders Other specify possibly related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular possibly related to research
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hematuria possibly related to research
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus possibly related to research
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Infusion related reaction definitely related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Edema limbs definitely related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin induration definitely related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pain definitely related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus definitely related to research
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction definitely related to research
|
4 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Weight loss possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Alanine aminotransferase increased possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anorexia possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dehydration possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Endocrine disorders - Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Eye disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hypotension possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lipase increased possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anal hemorrhage possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Diarrhea possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Headache possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Sinusitis possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fatigue possibly related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lymphocyte count decreased possibly related to research
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anemia possibly related to research
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Alkaline phosphatase increased possibly related to research
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Vomiting possibly related to research
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Nausea possibly related to research
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Eye disorders Other specify probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fever possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Flu-like symptoms possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 General disorders& administration site conditions Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hematuria possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Joint range of motion decreased possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Mucositis oral possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Musculoskeletal and connective tissue disorder Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hyperthyroidism probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lipase increased probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pruritus probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Serum amylase probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Skin and subcutaneous tissue disorders Other, specify, probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Urticaria probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Dry mouth probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hematuria probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Chills probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hyperhidrosis probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anemia probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Bullous dermatitis probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Dehydration probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hyponatremia probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Nausea probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hypothyroidism probably related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Injection site reaction probably related to research
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fatigue probably related to research
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fever probably related to research
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Infusion related reaction definitely related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Skin and subcutaneous tissue disorders Other specify definitely related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Arthritis definitely related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Injection site reaction definitely related to research
|
0 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pruritus definitely related to research
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Anemia possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Gastrointestinal disorders possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Eosinophilia probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Lipase increased probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Pruritus probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Rash maculo-papular possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Rash maculo-papular probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Pancreatitis probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Generalized muscle weakness possibly related to M7824
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Headache possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anorexia possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Arthralgia possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Aspartate aminotransferase increased possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Bloating possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Blood and lymphatic system disorders possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Diarrhea possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dizziness possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Endocrine disorders - Other specify possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flatulence possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flu-like symptoms possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Headache possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hematuria possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperhidrosis possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Insomnia possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Malaise possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Myalgia possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Nausea possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Vertigo possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Vomiting possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dizziness probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flu-like symptoms probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Headache probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperthyroidism probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Malaise probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Nausea probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pain probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills definitely related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever definitely related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Injection site reaction definitely related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus definitely related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders definitely related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Alanine aminotransferase increased possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Dehydration possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Endocrine disorders - Other specify possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fatigue possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fever possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Flu-like symptoms possibly related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Chills probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Hyperhidrosis probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Injection site reaction probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Lipase increased probably related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Injection site reaction definitely related to Bavarian-Nordic (BN)-brachyury
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Abdominal pain possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anorexia possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue possibly related to Anktiva (N803)0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Insomnia possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Mucositis oral possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Weight loss possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus probably related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Mucositis oral possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular probably related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemoglobinuria definitely related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anorexia possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fatigue possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Bloating possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Blood and lymphatic system disorders - Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills possibly related to M7824
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dry mouth possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Dry skin possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Weight loss possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pruritus probably related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular probably related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Rash maculo-papular possibly related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Rash maculo-papular probably related to Anktiva (N803)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Eosinophilia possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Eye disorders - Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue possibly related to M7824
|
1 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flatulence possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flu-like symptoms possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Gastrointestinal disorders - Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hematuria possibly related to M7824
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anorexia possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemolysis possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemorrhoidal hemorrhage possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Insomnia possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Mucositis oral possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hoarseness possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypothyroidism possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Insomnia possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pain possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus possibly related to M7824
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders - Other specify possibly related to M7824
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Weight loss possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus probably related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular probably related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemoglobinuria definitely related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Anorexia possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fatigue possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Mucositis oral possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Weight loss possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Pruritus probably related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular probably related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular possibly related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Pruritus probably related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Rash maculo-papular probably related to Epacadostat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Alanine aminotransferase increased possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Anal hemorrhage possibly related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hematuria probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Generalized edema probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Gingival pain probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypothyroidism probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Lipase increased probably related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Thyroid stimulating hormone probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Rash maculo-papular possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Skin and subcutaneous tissue disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Fatigue possibly related to M7824
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pain probably related to research
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders Other specify probably related to research
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fatigue probably related to research
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flu-like symptoms probably related to research
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Rash maculo-papular probably related to research
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hypotension probably related to research
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Pruritus probably related to research
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever probably related to research
|
2 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills probably related to research
|
3 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hyperthyroidism probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Flu-like symptoms definitely related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Hemoglobinuria definitely related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Skin and subcutaneous tissue disorders Other specify definitely related to research
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Bullous dermatitis definitely related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Chills definitely related to research
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Endocrine disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Eosinophilia possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Fever possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Endocrine disorders other specify probably related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 1 Arthralgia possibly related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Blood and lymphatic system disorders Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 Small intestine ulcer possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 2 injection site reaction definitely related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 weeks dose-limiting toxicity (DLT) periodNumber of participants with grades 3 4, and/or 5 serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803).
Outcome measures
| Measure |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=4 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=10 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 Participants
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Metabolism and nutrition disorders - Other, specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Tumor hemorrhage probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Tumor hemorrhage probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 4 Blood and lymphatic system disorders - Other specify possibly related to M7824
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Metabolism and nutrition disorders - Other, specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Tumor hemorrhage possibly related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Tumor hemorrhage possibly related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Endocrine disorders - Other specify probably related to research
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Endocrine disorders - Other specify probably related to M7824
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Enterocolitis probably related to research
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 3 Enterocolitis probably related to M7824
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 4 Blood and lymphatic system disorders - Other specify possibly related to research
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 4 Blood and lymphatic system disorders - Other specify possibly related to Anktiva (N-803)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Grade 5 related to research and/or any study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.Population: 58/59 participants were analyzed because one was deemed ineligible.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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 |
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=4 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion
n=10 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg and Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg.
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 Participants
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 Participants
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 Participants
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
4 Participants
|
10 Participants
|
13 Participants
|
13 Participants
|
12 Participants
|
6 Participants
|
Adverse Events
Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
Serious events: 8 serious events
Other events: 13 other events
Deaths: 1 deaths
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1
n=4 participants at risk
Phase I Dose Escalation, Cohort 1, Arm 1.1, Dose Level 1 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 1 =10mcg/kg, M7824 Dose Level 1 =1200mg
|
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2
n=10 participants at risk
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=13 participants at risk
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 participants at risk
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 participants at risk
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 participants at risk
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: Immune mediated neutropenia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Non-ST elevation myocardial infarction, Type II
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Endocrine disorders
Endocrine disorders - Other, specify: Isolated ACTH Insufficiency
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: colitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Mucosal bleeding
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Generalized edema
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Infections and infestations - Other, specify: Human ehrlichiosis and human anaplasmosis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Infections and infestations - Other, specify: Infected psoas hematoma
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Infections and infestations - Other, specify: Peritonsillar Abscess
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Joint infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Immune mediated diabetes
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Metastasectomy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
Other adverse events
| Measure |
Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1
n=4 participants at risk
Phase I Dose Escalation, Cohort 1, Arm 1.1, Dose Level 1 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 1 =10mcg/kg, M7824 Dose Level 1 =1200mg
|
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2
n=10 participants at risk
Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 Participants with any solid tumor M7824 + N-803 (accrual closed) N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A
n=13 participants at risk
Phase IIA Dose Expansion, Cohort 2, Arm 2.1A Participants with castration-resistant prostate cancer (CRPC) during Phase IIA M7824 + BN-Brachyury
|
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A
n=13 participants at risk
Phase IIA Dose Expansion, Cohort 2, Arm 2.2A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 during phase IIA N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B
n=12 participants at risk
Phase IIB Dose Expansion, Cohort 2, Arm 2.B Participants with CRPC requiring randomization in phase IIB M7824 + BN-Brachyury during phase IIB + N803 Dose Level 2 = 15mcg/kg M7824 Dose Level 2=1200mg
|
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A
n=6 participants at risk
Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A Participants with CRPC during Phase IIA M7824 + BN-Brachyury + N-803 + Epacadostat during phase IIA
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Cyst
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
40.0%
4/10 • Number of events 10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
69.2%
9/13 • Number of events 16 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
53.8%
7/13 • Number of events 10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
50.0%
3/6 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Periorbital edema
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.0%
3/10 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
75.0%
3/4 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
40.0%
4/10 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
46.2%
6/13 • Number of events 11 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
66.7%
4/6 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.0%
3/10 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
46.2%
6/13 • Number of events 16 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
83.3%
5/6 • Number of events 12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: B/l hydronephrosis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Bladder wall thickening
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Hydronephrosis
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Nocturia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Polyuria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Urinary hesitancy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: Bilateral hydrocele
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: Left testicular swelling
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Influenza
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Serum amylase increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 7 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Shingles
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Abdominal rash
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Calcinosis cutis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Dermatitis Herpetiformis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Diaphoresis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Keratoacanthoma
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Keratoacanthoma - R scalp
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Keratoacanthoma hand lesion
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Keratoacanthomas
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: L gluteal cyst
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Lichenoid dermatitis.
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Rash (facial)
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Red spot beneath L nipple
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Skin tear, gluteal fold
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Biopsy finger, L. third distal
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Left Knee
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: MOHS - Dorsal R hand for SCC and skin graft
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Oral Surgery - Removal of Surgical Bone
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Right Craniotomy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Slit his L index finger on home project
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Thrush
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Vascular disorders - Other, specify: Cervical Lymphadenopathy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Vascular disorders - Other, specify: Facial sweating
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
25.0%
3/12 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Vulval infection
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Weight gain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Weight loss
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
50.0%
5/10 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
61.5%
8/13 • Number of events 13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
41.7%
5/12 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
25.0%
3/12 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
40.0%
4/10 • Number of events 7 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
38.5%
5/13 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 7 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
90.0%
9/10 • Number of events 32 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 7 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 14 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
4/12 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
38.5%
5/13 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: Elevated D-Dimer
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: Elevated PTT
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: Immune-mediated neutropenia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: right neck LN
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Blurred vision
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
CPK increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Aortic aneurysm
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Cardiac disorders - Other, specify: CAD
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Coronary Calcification
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Chills
|
75.0%
3/4 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
90.0%
9/10 • Number of events 23 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
2/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.0%
3/10 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
4/12 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
50.0%
3/6 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: Foreign Body Sensation
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Edema face
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Edema limbs
|
50.0%
2/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Endocrine disorders
Endocrine disorders - Other, specify: Elevated A1C
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Endocrine disorders
Endocrine disorders - Other, specify: Isolated ACTH Deficiency (Central AI)
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Endocrine disorders
Endocrine disorders - Other, specify: Isolated ACTH Insufficiency
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
38.5%
5/13 • Number of events 10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Double Vision
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Iritis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Kaleidoscope vision
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: L 4th nerve palsy
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Ocular Hypertension
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Popped blood vessel in right eye
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Stye
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye disorders - Other, specify: Subconjunctival Hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
50.0%
5/10 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
53.8%
7/13 • Number of events 10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
61.5%
8/13 • Number of events 25 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
58.3%
7/12 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
70.0%
7/10 • Number of events 21 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
46.2%
6/13 • Number of events 14 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Flu like symptoms
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
69.2%
9/13 • Number of events 33 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
66.7%
8/12 • Number of events 16 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
50.0%
3/6 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
GGT increased
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Dilation of pancreatic duct
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Gastroenteritis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Gingival hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Hematochezia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 7 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: colitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: L Inguinal Hernia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Loose stools
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Loose stools 2-3/day
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Melena
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: hematochezia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Groin edema
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Lightheadedness
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Mucosal bleed, blood in urine
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Phantom Phantosmia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify:
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
General disorders and administration site conditions - Other, specify: gum bleeding
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
25.0%
3/12 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Generalized edema
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
80.0%
8/10 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Hematoma
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify: Transaminitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
20.0%
2/10 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
2/12 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Infections and infestations
Infections and infestations - Other, specify: Aphthous Ulcer
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Injection site reaction
|
100.0%
4/4 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
100.0%
10/10 • Number of events 85 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
84.6%
11/13 • Number of events 68 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
100.0%
13/13 • Number of events 126 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
100.0%
12/12 • Number of events 32 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
100.0%
6/6 • Number of events 23 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: Inguinal hernia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
50.0%
3/6 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Investigations - Other, specify: Decreased TSH
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Investigations - Other, specify: Elevated Acid Phosphatase
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Investigations - Other, specify: Elevated Ferritin
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Investigations - Other, specify: Low iron
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Investigations - Other, specify: Oral plaque-back of throat
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Investigations - Other, specify: TSH Decreased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
46.2%
6/13 • Number of events 16 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
25.0%
3/12 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
33.3%
2/6 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Localized edema
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
40.0%
4/10 • Number of events 4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
General disorders
Malaise
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Hypoglycemic Symptoms
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Immune mediated diabetes
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
1/4 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
15.4%
2/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Anterolisthesis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Bursitis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Compression fracture L2/L3
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Left fifth digit nodule
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Right Hip Pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Spinal canal stenosis
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Synovitis L ankle
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
8.3%
1/12 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.0%
3/10 • Number of events 5 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
23.1%
3/13 • Number of events 3 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
30.8%
4/13 • Number of events 7 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
41.7%
5/12 • Number of events 8 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/6 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/10 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/13 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
7.7%
1/13 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
0.00%
0/12 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
16.7%
1/6 • Number of events 1 • Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
58/59 participants were analyzed because one was deemed ineligible.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place