Trial Outcomes & Findings for Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus (NCT NCT03920267)
NCT ID: NCT03920267
Last Updated: 2026-03-20
Results Overview
A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
261 participants
Primary outcome timeframe
From Day 1 until 30 days after last dose (up to approximately 42 months)
Results posted on
2026-03-20
Participant Flow
Qualified participants who completed the study IM011-021 (NCT03252587) were randomized in this study.
Participant milestones
| Measure |
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
58
|
67
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
44
|
35
|
42
|
8
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
29
|
23
|
25
|
13
|
8
|
12
|
Reasons for withdrawal
| Measure |
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
Overall Study
Other reasons
|
11
|
11
|
11
|
6
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
4
|
5
|
2
|
2
|
|
Overall Study
Site terminated by sponsor
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
1
|
0
|
2
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
7
|
5
|
4
|
2
|
0
|
3
|
Baseline Characteristics
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
DEUC 12mg QD - DEUC 12mg QD
n=58 Participants
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 6mg BID - DEUC 6mg BID
n=73 Participants
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 3mg BID - DEUC 3mg BID
n=67 Participants
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 9.56 • n=154 Participants
|
43.4 years
STANDARD_DEVIATION 11.87 • n=151 Participants
|
41.1 years
STANDARD_DEVIATION 12.32 • n=305 Participants
|
44.6 years
STANDARD_DEVIATION 13.39 • n=104 Participants
|
41.5 years
STANDARD_DEVIATION 14.26 • n=22 Participants
|
44.1 years
STANDARD_DEVIATION 12.90 • n=21 Participants
|
41.6 years
STANDARD_DEVIATION 12.04 • n=26 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=154 Participants
|
68 Participants
n=151 Participants
|
62 Participants
n=305 Participants
|
19 Participants
n=104 Participants
|
18 Participants
n=22 Participants
|
17 Participants
n=21 Participants
|
235 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=154 Participants
|
5 Participants
n=151 Participants
|
5 Participants
n=305 Participants
|
2 Participants
n=104 Participants
|
3 Participants
n=22 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=154 Participants
|
20 Participants
n=151 Participants
|
21 Participants
n=305 Participants
|
4 Participants
n=104 Participants
|
9 Participants
n=22 Participants
|
7 Participants
n=21 Participants
|
80 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=154 Participants
|
53 Participants
n=151 Participants
|
46 Participants
n=305 Participants
|
17 Participants
n=104 Participants
|
11 Participants
n=22 Participants
|
14 Participants
n=21 Participants
|
180 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=154 Participants
|
4 Participants
n=151 Participants
|
3 Participants
n=305 Participants
|
1 Participants
n=104 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=154 Participants
|
13 Participants
n=151 Participants
|
7 Participants
n=305 Participants
|
5 Participants
n=104 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
37 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=154 Participants
|
5 Participants
n=151 Participants
|
7 Participants
n=305 Participants
|
2 Participants
n=104 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=154 Participants
|
44 Participants
n=151 Participants
|
43 Participants
n=305 Participants
|
12 Participants
n=104 Participants
|
14 Participants
n=22 Participants
|
15 Participants
n=21 Participants
|
164 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Others
|
7 Participants
n=154 Participants
|
7 Participants
n=151 Participants
|
7 Participants
n=305 Participants
|
1 Participants
n=104 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
27 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: From Day 1 until 30 days after last dose (up to approximately 42 months)Population: All treated participants
A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Outcome measures
| Measure |
DEUC 12mg QD - DEUC 12mg QD
n=58 Participants
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 6mg BID - DEUC 6mg BID
n=73 Participants
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 3mg BID - DEUC 3mg BID
n=67 Participants
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
Treatment Emergent Adverse Events
|
51 Participants
|
63 Participants
|
62 Participants
|
21 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
Treatment Emergent Serious Adverse Events
|
13 Participants
|
9 Participants
|
11 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 1 until 30 days after last dose (up to approximately 42 months)Population: All treated participants
Vital signs heart rate (HR) (beats/min), systolic blood pressure (SBP) (mmHG), and diastolic blood pressure (DBP) (mmHg).
Outcome measures
| Measure |
DEUC 12mg QD - DEUC 12mg QD
n=58 Participants
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 6mg BID - DEUC 6mg BID
n=73 Participants
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 3mg BID - DEUC 3mg BID
n=67 Participants
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs
HR VALUE > 100 AND CHANGE FROM BASELINE > 30
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
HR VALUE < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
SBP VALUE > 140 AND CHANGE FROM BASELINE > 20
|
4 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
SBP VALUE < 90 AND CHANGE FROM BASELINE < -20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
DBP VALUE > 90 AND CHANGE FROM BASELINE > 10
|
7 Participants
|
10 Participants
|
13 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Vital Signs
DBP VALUE < 55 AND CHANGE FROM BASELINE < -10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 until 30 days after last dose (up to approximately 42 months)Population: All treated participants
Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality
Outcome measures
| Measure |
DEUC 12mg QD - DEUC 12mg QD
n=58 Participants
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 6mg BID - DEUC 6mg BID
n=73 Participants
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 3mg BID - DEUC 3mg BID
n=67 Participants
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
n=21 Participants
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HEMOGLOBIN (G/L) GRADE 3
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
LYMPHOCYTES (10^9/L) GRADE 3
|
3 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
LYMPHOCYTES (10^9/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
NEUTROPHILS (10^9/L) GRADE 3
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
NEUTROPHILS (10^9/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
PLATELETS (10^9/L) GRADE 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
PLATELETS (10^9/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
LEUKOCYTES (10^9/L) GRADE 3
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
LEUKOCYTES (10^9/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ALBUMIN (G/L) GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ALKALINE PHOSPHATASE (IU/L) GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ALKALINE PHOSPHATASE (IU/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ALANINE AMINOTRANSFERASE (U/L) GRADE 3
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ALANINE AMINOTRANSFERASE (U/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ASPARTATE AMINOTRANSFERASE (U/L) GRADE 3
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
ASPARTATE AMINOTRANSFERASE (U/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
BILIRUBIN (UMOL/L) GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
BILIRUBIN (UMOL/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
CREATINE KINASE (IU/L) GRADE 3
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
CREATINE KINASE (IU/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
CREATININE (UMOL/L) GRADE 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
CREATININE (UMOL/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
GAMMA GLUTAMYL TRANSFERASE (U/L) GRADE 3
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
GAMMA GLUTAMYL TRANSFERASE (U/L) GRADE 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
GLUCOSE (MMOL/L) GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
GLUCOSE (MMOL/L) GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERCALCEMIA GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERCALCEMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERKALEMIA GRADE 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERKALEMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERMAGNESEMIA GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERMAGNESEMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERNATREMIA GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPERNATREMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPOCALCEMIA GRADE 3
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPOCALCEMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPOKALEMIA GRADE 3
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPOKALEMIA GRADE 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPOMAGNESEMIA GRADE 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPOMAGNESEMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPONATREMIA GRADE 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
HYPONATREMIA GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
DEUC 12mg QD - DEUC 12mg QD
Serious events: 13 serious events
Other events: 43 other events
Deaths: 0 deaths
DEUC 6mg BID - DEUC 6mg BID
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
DEUC 3mg BID - DEUC 3mg BID
Serious events: 11 serious events
Other events: 51 other events
Deaths: 1 deaths
PBO BID - DEUC 12mg QD
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
PBO BID - DEUC 6mg BID
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
PBO BID - DEUC 3mg BID
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DEUC 12mg QD - DEUC 12mg QD
n=58 participants at risk
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 6mg BID - DEUC 6mg BID
n=73 participants at risk
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 3mg BID - DEUC 3mg BID
n=67 participants at risk
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
n=21 participants at risk
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
n=21 participants at risk
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
n=21 participants at risk
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Appendicitis
|
3.4%
2/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
COVID-19
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
COVID-19 pneumonia
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
2.7%
2/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Cellulitis
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Device related infection
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Herpes zoster
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Pneumonia
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Pyelonephritis acute
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Sepsis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
3.4%
2/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Nervous system disorder
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Seizure
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
Other adverse events
| Measure |
DEUC 12mg QD - DEUC 12mg QD
n=58 participants at risk
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
|
DEUC 6mg BID - DEUC 6mg BID
n=73 participants at risk
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
DEUC 3mg BID - DEUC 3mg BID
n=67 participants at risk
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
PBO BID - DEUC 12mg QD
n=21 participants at risk
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
|
PBO BID - DEUC 6mg BID
n=21 participants at risk
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
|
PBO BID - DEUC 3mg BID
n=21 participants at risk
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
|
|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
3.4%
2/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Bronchitis
|
8.6%
5/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.0%
4/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
COVID-19
|
27.6%
16/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
28.8%
21/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
35.8%
24/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
19.0%
4/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
19.0%
4/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
23.8%
5/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Cystitis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
5.5%
4/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
7.5%
5/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Gastroenteritis
|
5.2%
3/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.1%
3/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.5%
3/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Herpes zoster
|
5.2%
3/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
12.3%
9/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
7.5%
5/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Influenza
|
3.4%
2/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
5.5%
4/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.0%
4/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Nasopharyngitis
|
22.4%
13/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
13.7%
10/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
19.4%
13/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
19.0%
4/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
23.8%
5/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Oral herpes
|
6.9%
4/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.8%
5/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.1%
3/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.0%
4/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Pharyngotonsillitis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Sinusitis
|
3.4%
2/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
8.2%
6/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Tonsillitis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
10.4%
7/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.0%
4/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
2.7%
2/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.5%
3/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
3/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.8%
5/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.5%
3/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
19.0%
4/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
5.5%
4/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Gastrointestinal disorders
Nausea
|
6.9%
4/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
2.7%
2/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.8%
5/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Upper respiratory tract infection
|
19.0%
11/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
15.1%
11/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
19.4%
13/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Infections and infestations
Urinary tract infection
|
13.8%
8/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
21.9%
16/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
16.4%
11/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
2.7%
2/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
5.5%
4/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
5.5%
4/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.2%
3/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.0%
4/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.8%
5/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
4/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.6%
7/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
2.7%
2/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Nervous system disorders
Headache
|
12.1%
7/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
6.8%
5/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
10.4%
7/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.1%
3/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
3.0%
2/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.2%
3/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.1%
3/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.5%
1/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
14.3%
3/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
1.4%
1/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
9.5%
2/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
5.5%
4/73 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
7.5%
5/67 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
4.8%
1/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
0.00%
0/21 • All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
All treated population
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER