Trial Outcomes & Findings for Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia (NCT NCT05368558)
NCT ID: NCT05368558
Last Updated: 2025-10-20
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)
Results posted on
2025-10-20
Participant Flow
Participant milestones
| Measure |
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6-week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=10 from DBP Placebo
|
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=1 from DBP Placebo N=2 from DBP Cariprazine 3 mg N=1 from DBP Cariprazine 6 mg
|
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=2 from DBP Cariprazine 3 mg N=8 from DBP Cariprazine 6 mg
|
SF DBP Placebo
Safety Follow up (SF) for DBP Placebo participants.
|
SF DBP Cariprazine 3 mg
SF for DBP Cariprazine 3 mg participants.
|
SF DBP Cariprazine 6 mg
SF for DBP Cariprazine 6 mg participants.
|
SF BEP Cariprazine 1.5 mg
SF for BEP Cariprazine 1.5 mg participants.
|
SF BEP Cariprazine 3 mg
SF for BEP Cariprazine 3 mg participants.
|
SF BEP Cariprazine 6 mg
SF for BEP Cariprazine 6 mg participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind Period (DBP)
STARTED
|
16
|
5
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Period (DBP)
COMPLETED
|
15
|
4
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Period (DBP)
NOT COMPLETED
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period (BEP)
STARTED
|
0
|
0
|
0
|
10
|
4
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period (BEP)
COMPLETED
|
0
|
0
|
0
|
8
|
4
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period (BEP)
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Follow-up DBP (SF DBP)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
4
|
11
|
0
|
0
|
0
|
|
Safety Follow-up DBP (SF DBP)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
4
|
0
|
0
|
0
|
|
Safety Follow-up DBP (SF DBP)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
3
|
7
|
0
|
0
|
0
|
|
Safety Follow-up BEP (SF BEP)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
4
|
10
|
|
Safety Follow-up BEP (SF BEP)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
4
|
10
|
|
Safety Follow-up BEP (SF BEP)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6-week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=10 from DBP Placebo
|
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=1 from DBP Placebo N=2 from DBP Cariprazine 3 mg N=1 from DBP Cariprazine 6 mg
|
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=2 from DBP Cariprazine 3 mg N=8 from DBP Cariprazine 6 mg
|
SF DBP Placebo
Safety Follow up (SF) for DBP Placebo participants.
|
SF DBP Cariprazine 3 mg
SF for DBP Cariprazine 3 mg participants.
|
SF DBP Cariprazine 6 mg
SF for DBP Cariprazine 6 mg participants.
|
SF BEP Cariprazine 1.5 mg
SF for BEP Cariprazine 1.5 mg participants.
|
SF BEP Cariprazine 3 mg
SF for BEP Cariprazine 3 mg participants.
|
SF BEP Cariprazine 6 mg
SF for BEP Cariprazine 6 mg participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind Period (DBP)
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period (BEP)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period (BEP)
Study terminated by sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Blinded Extension Period (BEP)
other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
DBP Placebo
n=16 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=13 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 13.70 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 11.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
SCI-PANSS Total Score at Baseline
|
94.6 score on a scale
STANDARD_DEVIATION 8.70 • n=5 Participants
|
99.8 score on a scale
STANDARD_DEVIATION 8.17 • n=7 Participants
|
91.8 score on a scale
STANDARD_DEVIATION 7.37 • n=5 Participants
|
94.3 score on a scale
STANDARD_DEVIATION 8.33 • n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)Population: Safety Population includes all randomized participants who receive at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
DBP Placebo
n=16 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=13 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
12 Participants
|
2 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline (Wk 0) to Week 6Population: mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=11 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=10 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.
|
-15.2 score on a scale
Standard Deviation 12.21
|
-5.6 score on a scale
Standard Deviation 10.38
|
-30.2 score on a scale
Standard Deviation 17.47
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Week 6Population: mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=11 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=10 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in CGI-S Score From Baseline (Wk 0) to Week 6
|
-0.6 score on a scale
Standard Deviation 0.92
|
-0.4 score on a scale
Standard Deviation 0.55
|
-1.3 score on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Week 6Population: mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=11 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=10 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6
|
-4.7 score on a scale
Standard Deviation 4.67
|
-2.2 score on a scale
Standard Deviation 3.35
|
-8.7 score on a scale
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Week 6Population: mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=11 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=10 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6
|
-3.2 score on a scale
Standard Deviation 7.49
|
-2.8 score on a scale
Standard Deviation 9.20
|
-14.5 score on a scale
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Week 6Population: mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=11 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=10 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6
|
-3.5 score on a scale
Standard Deviation 3.86
|
-0.2 score on a scale
Standard Deviation 3.27
|
-8.1 score on a scale
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Week 6Population: mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=11 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=10 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6
|
-3.8 score on a scale
Standard Deviation 3.71
|
-0.4 score on a scale
Standard Deviation 3.78
|
-9.1 score on a scale
Standard Deviation 6.82
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) and Week 6 to Week 24Population: BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=5 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=3 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=4 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24
Baseline (Wk 0) to Week 24
|
-19.2 score on a scale
Standard Deviation 19.52
|
-19.3 score on a scale
Standard Deviation 30.09
|
-22.5 score on a scale
Standard Deviation 25.16
|
|
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24
Week 6 to Week 24
|
-4.0 score on a scale
Standard Deviation 16.05
|
2.0 score on a scale
Standard Deviation 4.58
|
6.0 score on a scale
Standard Deviation 17.51
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) and Week 6 to Week 24Population: BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=5 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=3 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=4 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24
Week 6 to Week 24
|
-0.4 score on a scale
Standard Deviation 1.14
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.82
|
|
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24
Baseline (Wk 0) to Week 24
|
-0.8 score on a scale
Standard Deviation 0.84
|
-1.3 score on a scale
Standard Deviation 2.31
|
-1.0 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) and Week 6 to Week 24Population: BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=5 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=3 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=4 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Baseline (Wk 0) to Week 24
|
-5.2 score on a scale
Standard Deviation 5.36
|
-4.3 score on a scale
Standard Deviation 7.51
|
-6.8 score on a scale
Standard Deviation 6.60
|
|
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Week 6 to Week 24
|
-0.2 score on a scale
Standard Deviation 4.38
|
0.3 score on a scale
Standard Deviation 0.58
|
1.5 score on a scale
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) and Week 6 to Week 24Population: BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=5 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=3 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=4 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24
Baseline (Wk 0) to Week 24
|
-11.6 score on a scale
Standard Deviation 13.52
|
-5.0 score on a scale
Standard Deviation 14.00
|
-13.3 score on a scale
Standard Deviation 20.19
|
|
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24
Week 6 to Week 24
|
-7.6 score on a scale
Standard Deviation 18.28
|
2.7 score on a scale
Standard Deviation 5.51
|
-1.8 score on a scale
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) and Week 6 to Week 24Population: BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=5 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=3 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=4 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Baseline (Wk 0) to Week 24
|
-6.4 score on a scale
Standard Deviation 3.85
|
-5.0 score on a scale
Standard Deviation 6.24
|
-5.3 score on a scale
Standard Deviation 9.64
|
|
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Week 6 to Week 24
|
-2.8 score on a scale
Standard Deviation 4.09
|
-1.3 score on a scale
Standard Deviation 2.52
|
2.3 score on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) and Week 6 to Week 24Population: BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
DBP Placebo
n=5 Participants
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=3 Participants
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=4 Participants
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
|---|---|---|---|
|
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24
Baseline (Wk 0) to Week 24
|
-5.2 score on a scale
Standard Deviation 4.09
|
-6.7 score on a scale
Standard Deviation 9.29
|
-6.0 score on a scale
Standard Deviation 9.76
|
|
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24
Week 6 to Week 24
|
-1.6 score on a scale
Standard Deviation 3.78
|
-1.0 score on a scale
Standard Deviation 1.00
|
2.0 score on a scale
Standard Deviation 4.16
|
Adverse Events
DBP Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DBP Cariprazine 3 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DBP Cariprazine 6 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BEP Cariprazine 1.5 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
BEP Cariprazine 3 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BEP Cariprazine 6 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SF DBP Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SF DBP Cariprazine 3 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SF DBP Cariprazine 6 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
SF BEP Cariprazine 1.5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SF BEP Cariprazine 3 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
SF BEP Cariprazine 6 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DBP Placebo
n=16 participants at risk
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 participants at risk
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=13 participants at risk
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
BEP Cariprazine 1.5 mg
n=10 participants at risk
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal modal (most frequent) daily dose during the 18-week BEP.
|
BEP Cariprazine 3 mg
n=4 participants at risk
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal modal (most frequent) daily dose during the 18-week BEP.
|
BEP Cariprazine 6 mg
n=10 participants at risk
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal (most frequent) daily dose during the 18-week BEP.
|
SF DBP Placebo
n=5 participants at risk
Safety Follow up (SF) for DBP Placebo participants.
|
SF DBP Cariprazine 3 mg
n=1 participants at risk
SF for DBP Cariprazine 3 mg participants.
|
SF DBP Cariprazine 6 mg
n=4 participants at risk
SF for DBP Cariprazine 6 mg participants.
|
SF BEP Cariprazine 1.5 mg
n=10 participants at risk
SF for BEP Cariprazine 1.5 mg participants.
|
SF BEP Cariprazine 3 mg
n=4 participants at risk
SF for BEP Cariprazine 3 mg participants.
|
SF BEP Cariprazine 6 mg
n=10 participants at risk
SF for BEP Cariprazine 6 mg participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
AGITATION
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
Other adverse events
| Measure |
DBP Placebo
n=16 participants at risk
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
|
DBP Cariprazine 3 mg
n=5 participants at risk
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
DBP Cariprazine 6 mg
n=13 participants at risk
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
|
BEP Cariprazine 1.5 mg
n=10 participants at risk
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal modal (most frequent) daily dose during the 18-week BEP.
|
BEP Cariprazine 3 mg
n=4 participants at risk
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal modal (most frequent) daily dose during the 18-week BEP.
|
BEP Cariprazine 6 mg
n=10 participants at risk
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal (most frequent) daily dose during the 18-week BEP.
|
SF DBP Placebo
n=5 participants at risk
Safety Follow up (SF) for DBP Placebo participants.
|
SF DBP Cariprazine 3 mg
n=1 participants at risk
SF for DBP Cariprazine 3 mg participants.
|
SF DBP Cariprazine 6 mg
n=4 participants at risk
SF for DBP Cariprazine 6 mg participants.
|
SF BEP Cariprazine 1.5 mg
n=10 participants at risk
SF for BEP Cariprazine 1.5 mg participants.
|
SF BEP Cariprazine 3 mg
n=4 participants at risk
SF for BEP Cariprazine 3 mg participants.
|
SF BEP Cariprazine 6 mg
n=10 participants at risk
SF for BEP Cariprazine 6 mg participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
DRY EYE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Eye disorders
IRIDOCYCLITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Eye disorders
UVEITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
15.4%
2/13 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
General disorders
FEELING ABNORMAL
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
General disorders
PYREXIA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
2/10 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
40.0%
4/10 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
HORDEOLUM
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
2/10 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
PERIODONTITIS
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Injury, poisoning and procedural complications
CHILLBLAINS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Injury, poisoning and procedural complications
IMMUNISATION REACTION
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Injury, poisoning and procedural complications
POST VACCINATION SYNDROME
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
BLOOD SODIUM DECREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
HIGH DENSITY LIPOPROTEIN INCREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
AKATHISIA
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
30.8%
4/13 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
40.0%
2/5 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
PARKINSONISM
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
15.4%
2/13 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
6.2%
1/16 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
15.4%
2/13 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
LOGORRHOEA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
25.0%
1/4 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
NIGHTMARE
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
25.0%
4/16 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
20.0%
1/5 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Reproductive system and breast disorders
SCROTAL ERYTHEMA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
10.0%
1/10 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
6.2%
1/16 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/13 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/16 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
7.7%
1/13 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/5 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/1 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/4 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
0.00%
0/10 • All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER