Trial Outcomes & Findings for Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors (NCT NCT03964727)
NCT ID: NCT03964727
Last Updated: 2026-01-30
Results Overview
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
223 participants
Primary outcome timeframe
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Results posted on
2026-01-30
Participant Flow
Participants were enrolled at study sites in the United States, France, Australia, Hong Kong, Spain, Taiwan, Canada, and Belgium.
396 participants were screened. Data submitted represent primary analysis performed on data collected by the Primary Completion Date. Complete data will be submitted within 1 year of the study completion date.
Participant milestones
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]
Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression received sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)
Participants with HNSCC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: Endometrial Cancer (EC)
Participants with EC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Participants with ES-SCLC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
34
|
31
|
43
|
41
|
43
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
31
|
34
|
31
|
43
|
41
|
43
|
Reasons for withdrawal
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]
Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression received sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)
Participants with HNSCC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: Endometrial Cancer (EC)
Participants with EC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Participants with ES-SCLC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
14
|
23
|
25
|
31
|
28
|
32
|
|
Overall Study
Still on study
|
0
|
6
|
2
|
4
|
7
|
8
|
|
Overall Study
Reason not specified
|
16
|
3
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
7
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
Total~(N=223)
n=223 Participants
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=35 Participants
|
16 Participants
n=4328 Participants
|
14 Participants
n=8687 Participants
|
32 Participants
n=269 Participants
|
15 Participants
n=530 Participants
|
17 Participants
n=170 Participants
|
110 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=35 Participants
|
18 Participants
n=4328 Participants
|
17 Participants
n=8687 Participants
|
11 Participants
n=269 Participants
|
26 Participants
n=530 Participants
|
26 Participants
n=170 Participants
|
113 Participants
n=7 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 8.7 • n=35 Participants
|
64 years
STANDARD_DEVIATION 10.5 • n=4328 Participants
|
65 years
STANDARD_DEVIATION 8.4 • n=8687 Participants
|
61 years
STANDARD_DEVIATION 6.8 • n=269 Participants
|
66 years
STANDARD_DEVIATION 9.1 • n=530 Participants
|
66 years
STANDARD_DEVIATION 8.2 • n=170 Participants
|
64 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=35 Participants
|
19 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
10 Participants
n=269 Participants
|
41 Participants
n=530 Participants
|
23 Participants
n=170 Participants
|
116 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=35 Participants
|
15 Participants
n=4328 Participants
|
23 Participants
n=8687 Participants
|
33 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
20 Participants
n=170 Participants
|
107 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
2 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=35 Participants
|
31 Participants
n=4328 Participants
|
29 Participants
n=8687 Participants
|
40 Participants
n=269 Participants
|
34 Participants
n=530 Participants
|
36 Participants
n=170 Participants
|
200 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
3 Participants
n=269 Participants
|
5 Participants
n=530 Participants
|
5 Participants
n=170 Participants
|
17 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
23 Participants
n=35 Participants
|
26 Participants
n=4328 Participants
|
24 Participants
n=8687 Participants
|
33 Participants
n=269 Participants
|
21 Participants
n=530 Participants
|
36 Participants
n=170 Participants
|
163 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
6 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
1 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
16 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
4 Participants
n=269 Participants
|
8 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
20 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
2 Participants
n=269 Participants
|
2 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
3 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
7 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Unknow or Not Reported
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
2 Participants
n=269 Participants
|
6 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
12 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=35 Participants
|
32 Participants
n=4328 Participants
|
26 Participants
n=8687 Participants
|
34 Participants
n=269 Participants
|
28 Participants
n=530 Participants
|
22 Participants
n=170 Participants
|
173 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
5 Participants
n=269 Participants
|
2 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
12 Participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
4 Participants
n=530 Participants
|
5 Participants
n=170 Participants
|
11 Participants
n=7 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
5 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
9 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
9 Participants
n=170 Participants
|
9 Participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
1 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
1 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: The Full Analysis Set included all participants who received at least 1 dose of SG.
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
|
12.9 percentage of participants
Interval 3.6 to 29.8
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
16.3 percentage of participants
Interval 6.8 to 30.7
|
26.8 percentage of participants
Interval 14.2 to 42.9
|
44.2 percentage of participants
Interval 29.1 to 60.1
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set were analyzed.
ORR was defined as the percentage of participants who had the best overall response of either CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
18.6 percentage of participants
Interval 8.4 to 33.4
|
24.4 percentage of participants
Interval 12.4 to 40.3
|
44.2 percentage of participants
Interval 29.1 to 60.1
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set who achieved confirmed CR or PR/with objective response were analyzed.
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first progression of disease (PD) or death from any cause,whichever comes first. Response are according to RECIST 1.1 by BICR for each histological cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR: \>30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=1 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=3 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=5 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=8 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=10 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=19 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment
|
2.86 months
Upper and lower limit of confidence interval (CI) were not estimable due to low number of participants with events.
|
22.08 months
Interval 10.55 to
Upper limit of CI was not estimable due to low number of participants with events.
|
4.70 months
Interval 2.1 to
Upper limit of CI was not estimable due to low number of participants with events.
|
8.67 months
Interval 2.83 to
Upper limit of CI was not estimable due to low number of participants with events.
|
16.00 months
Interval 2.76 to
Upper limit of CI was not estimable due to low number of participants with events.
|
6.01 months
Interval 2.92 to 10.22
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set were analyzed.
CBR was percentage of participants with best overall response of CR, PR,or durable stable disease (SD) (SD ≥ 6 months after first dose). Responses are according to RECIST 1.1 by BICR.CR: Disappearance of all target and non-target lesions;\& normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD, taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of \>20% in sum of diameters of target lesions, taking reference of smallest sum(this includes baseline sum if smallest on study), the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. Two-sided CI was based on Clopper-Pearson method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment
|
29.0 percentage of participants
Interval 14.2 to 48.0
|
23.5 percentage of participants
Interval 10.7 to 41.2
|
19.4 percentage of participants
Interval 7.5 to 37.5
|
27.9 percentage of participants
Interval 15.3 to 43.7
|
39.0 percentage of participants
Interval 24.2 to 55.5
|
46.5 percentage of participants
Interval 31.2 to 62.3
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set were analyzed.
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment
|
4.11 months
Interval 2.5 to 7.52
|
4.24 months
Interval 2.27 to 7.59
|
2.73 months
Interval 1.41 to 5.49
|
3.25 months
Interval 1.74 to 6.47
|
5.55 months
Interval 2.79 to 9.59
|
4.40 months
Interval 3.19 to 6.67
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set who achieved confirmed CR or PR/with objective response were analyzed.
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first PD or death from any cause, whichever comes first. Responses are based on investigator-assessed tumor response by RECIST 1.1 criteria for each histological cohort.CR:Disappearance of all target and non-target lesions;and normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in the sum of the LD of target lesions,taking as reference the baseline sum LD. Disease progression was defined as increase of \>20% in sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study).In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=4 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=2 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=2 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=7 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=11 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=19 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
DOR According to RECIST 1.1 by Investigator's Assessment
|
8.56 months
Interval 6.41 to
Upper limit of CI was not estimable due to low number of participants with events.
|
21.09 months
Interval 11.1 to
Upper limit of CI was not estimable due to low number of participants with events.
|
7.87 months
Interval 6.05 to
Upper limit of CI was not estimable due to low number of participants with events.
|
4.21 months
Interval 2.6 to 8.67
|
9.92 months
Interval 2.79 to
Upper limit of CI was not estimable due to low number of participants with events.
|
6.31 months
Interval 3.52 to 10.22
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set were analyzed.
CBR was the percentage of participants with the best overall response of CR, PR,or durable SD (SD ≥ 6 months after first dose) by investigator-assessed tumor response using RECIST 1.1 criteria.CR:Disappearance of all target and non-target lesions;\& normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in sum of LD of target lesions,taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD,taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of \>20% in sum of diameters of target lesions,taking reference of smallest sum(this includes baseline sum if smallest on study),the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions.Two-sided CI was based on Clopper-Pearson method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
CBR According to RECIST 1.1 by Investigator's Assessment
|
32.3 percentage of participants
Interval 16.7 to 51.4
|
20.6 percentage of participants
Interval 8.7 to 37.9
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
30.2 percentage of participants
Interval 17.2 to 46.1
|
41.5 percentage of participants
Interval 26.3 to 57.9
|
48.8 percentage of participants
Interval 33.3 to 64.5
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set were analyzed.
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
PFS According to RECIST 1.1 by Investigator's Assessment
|
2.79 months
Interval 1.48 to 7.82
|
3.78 months
Interval 1.41 to 5.65
|
2.56 months
Interval 1.41 to 5.49
|
4.14 months
Interval 1.71 to 5.78
|
4.96 months
Interval 2.76 to 9.82
|
4.40 months
Interval 3.81 to 6.11
|
SECONDARY outcome
Timeframe: Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 yearsPopulation: Participants in the Full Analysis Set were analyzed.
OS was defined as the interval from the first dose date of drug to death from any cause. OS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
14.26 months
Interval 4.34 to 23.72
|
11.02 months
Interval 4.24 to 20.47
|
7.29 months
Interval 5.16 to 10.22
|
8.97 months
Interval 7.52 to 12.22
|
14.95 months
Interval 5.88 to 21.42
|
11.73 months
Interval 6.57 to 14.72
|
SECONDARY outcome
Timeframe: Up to 7.2 yearsA TEAE was defined as any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug or the day before initiation of subsequent therapy, whichever comes first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 7.2 yearsA treatment-emergent laboratory abnormality was defined as any value that increased at least 1 toxicity grade from baseline during the treatment-emergent period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29Population: The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol \& had at least 1 evaluable posttreatment serum concentration of Total SN-38. Participants with available data were analyzed.As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts\[Cohort 1 Group 1:NSCLC \[Adenocarcinoma + SCC\],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)\] were combined. The combined PK data was summarized \& reported.
Cmax was defined as the maximum observed concentration of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=58 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=39 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=39 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=38 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 7 Day 1
|
4220 nanograms per milliliter (ng/mL)
Standard Deviation 949
|
3750 nanograms per milliliter (ng/mL)
Standard Deviation 1090
|
4430 nanograms per milliliter (ng/mL)
Standard Deviation 915
|
4210 nanograms per milliliter (ng/mL)
Standard Deviation 1160
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 11 Day 1
|
4210 nanograms per milliliter (ng/mL)
Standard Deviation 1200
|
4720 nanograms per milliliter (ng/mL)
Standard Deviation 1210
|
4390 nanograms per milliliter (ng/mL)
Standard Deviation 1030
|
4250 nanograms per milliliter (ng/mL)
Standard Deviation 1390
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 17 Day 1
|
4620 nanograms per milliliter (ng/mL)
Standard Deviation 849
|
4700 nanograms per milliliter (ng/mL)
Standard Deviation 647
|
4970 nanograms per milliliter (ng/mL)
Standard Deviation 922
|
5510 nanograms per milliliter (ng/mL)
Standard Deviation 783
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 23 Day 1
|
5140 nanograms per milliliter (ng/mL)
Standard Deviation 1090
|
—
|
4880 nanograms per milliliter (ng/mL)
Standard Deviation 1050
|
5420 nanograms per milliliter (ng/mL)
Standard Deviation 912
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 29 Day 1
|
4580 nanograms per milliliter (ng/mL)
Standard Deviation 679
|
—
|
4720 nanograms per milliliter (ng/mL)
Standard Deviation 499
|
5520 nanograms per milliliter (ng/mL)
Standard Deviation 424
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 35 Day 1
|
4360 nanograms per milliliter (ng/mL)
Standard Deviation 1100
|
—
|
4110 nanograms per milliliter (ng/mL)
Standard Deviation 898
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 41 Day 1
|
5230 nanograms per milliliter (ng/mL)
Standard Deviation 1150
|
—
|
5450 nanograms per milliliter (ng/mL)
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 47 Day 1
|
4260 nanograms per milliliter (ng/mL)
Standard Deviation 1610
|
—
|
4580 nanograms per milliliter (ng/mL)
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 53 Day 1
|
—
|
—
|
5210 nanograms per milliliter (ng/mL)
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 3 Day 1
|
4280 nanograms per milliliter (ng/mL)
Standard Deviation 1420
|
3930 nanograms per milliliter (ng/mL)
Standard Deviation 1080
|
4440 nanograms per milliliter (ng/mL)
Standard Deviation 1130
|
4150 nanograms per milliliter (ng/mL)
Standard Deviation 1040
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 2 Day 1
|
4420 nanograms per milliliter (ng/mL)
Standard Deviation 1010
|
4210 nanograms per milliliter (ng/mL)
Standard Deviation 807
|
4640 nanograms per milliliter (ng/mL)
Standard Deviation 1840
|
4330 nanograms per milliliter (ng/mL)
Standard Deviation 760
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cycle 1 Day 1
|
4790 nanograms per milliliter (ng/mL)
Standard Deviation 1170
|
4410 nanograms per milliliter (ng/mL)
Standard Deviation 734
|
4920 nanograms per milliliter (ng/mL)
Standard Deviation 1060
|
4670 nanograms per milliliter (ng/mL)
Standard Deviation 738
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29Population: The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol \& had at least 1 evaluable posttreatment serum concentration of Free SN-38. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for the 3 NSCLC cohorts\[Cohort 1 Group 1:NSCLC \[Adenocarcinoma + SCC\],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)\] were combined.The combined PK data was summarized \& reported.
Cmax was defined as the maximum observed concentration of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=58 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=39 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=39 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=37 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Free SN-38
Cycle 1 Day 1
|
65.4 ng/mL
Standard Deviation 23.5
|
200 ng/mL
Standard Deviation 386
|
94.5 ng/mL
Standard Deviation 143
|
78.5 ng/mL
Standard Deviation 60.6
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 2 Day 1
|
67.0 ng/mL
Standard Deviation 40.2
|
94.9 ng/mL
Standard Deviation 160
|
70.2 ng/mL
Standard Deviation 69.1
|
87.1 ng/mL
Standard Deviation 65.8
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 3 Day 1
|
107 ng/mL
Standard Deviation 277
|
46.8 ng/mL
Standard Deviation 17.2
|
62.5 ng/mL
Standard Deviation 41.1
|
74.4 ng/mL
Standard Deviation 75.9
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 7 Day 1
|
64.6 ng/mL
Standard Deviation 26.1
|
70.7 ng/mL
Standard Deviation 50.1
|
63.8 ng/mL
Standard Deviation 57.2
|
78.7 ng/mL
Standard Deviation 63.3
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 11 Day 1
|
54.6 ng/mL
Standard Deviation 11.1
|
57.1 ng/mL
Standard Deviation 29.8
|
59.3 ng/mL
Standard Deviation 54.0
|
51.6 ng/mL
Standard Deviation 25.2
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 17 Day 1
|
56.6 ng/mL
Standard Deviation 11.0
|
52.1 ng/mL
Standard Deviation 18.1
|
73.3 ng/mL
Standard Deviation 37.6
|
74.6 ng/mL
Standard Deviation 35.2
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 23 Day 1
|
72.8 ng/mL
Standard Deviation 35.9
|
—
|
57.3 ng/mL
Standard Deviation 21.2
|
53.0 ng/mL
Standard Deviation 17.3
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 29 Day 1
|
67.0 ng/mL
Standard Deviation 23.0
|
—
|
158 ng/mL
Standard Deviation 140
|
170 ng/mL
Standard Deviation 138
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 35 Day 1
|
69.4 ng/mL
Standard Deviation 51.1
|
—
|
90.4 ng/mL
Standard Deviation 81.3
|
—
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 41 Day 1
|
76.1 ng/mL
Standard Deviation 32.3
|
—
|
158 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 47 Day 1
|
41.9 ng/mL
Standard Deviation 8.77
|
—
|
369 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Cmax of Free SN-38
Cycle 53 Day 1
|
—
|
—
|
239 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29Population: The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol \& had at least 1 evaluable posttreatment serum concentration of Total Antibody. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts\[Cohort 1 Group 1:NSCLC \[Adenocarcinoma + SCC\],Cohort 1 Group 2:NSCLC(Adenocarcinoma), \& Cohort 1 Group 3:NSCLC(SCC)\] were combined. The combined PK data was summarized \& reported.
Cmax was defined as the maximum observed concentration of total antibody of SG \[hRS7 immunoglobulin (IgG) and hRS7-SN-38\]. Cycle length=21 days.
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=57 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=38 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=38 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=38 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Total Antibody
Cycle 1 Day 1
|
232000 ng/mL
Standard Deviation 79200
|
209000 ng/mL
Standard Deviation 54700
|
249000 ng/mL
Standard Deviation 77700
|
222000 ng/mL
Standard Deviation 49400
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 2 Day 1
|
245000 ng/mL
Standard Deviation 79700
|
234000 ng/mL
Standard Deviation 98700
|
258000 ng/mL
Standard Deviation 114000
|
231000 ng/mL
Standard Deviation 73000
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 3 Day 1
|
260000 ng/mL
Standard Deviation 108000
|
234000 ng/mL
Standard Deviation 80600
|
294000 ng/mL
Standard Deviation 114000
|
240000 ng/mL
Standard Deviation 82100
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 7 Day 1
|
272000 ng/mL
Standard Deviation 139000
|
245000 ng/mL
Standard Deviation 108000
|
305000 ng/mL
Standard Deviation 116000
|
260000 ng/mL
Standard Deviation 107000
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 11 Day 1
|
287000 ng/mL
Standard Deviation 120000
|
330000 ng/mL
Standard Deviation 114000
|
339000 ng/mL
Standard Deviation 123000
|
315000 ng/mL
Standard Deviation 132000
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 17 Day 1
|
313000 ng/mL
Standard Deviation 95800
|
369000 ng/mL
Standard Deviation 179000
|
338000 ng/mL
Standard Deviation 127000
|
380000 ng/mL
Standard Deviation 128000
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 23 Day 1
|
356000 ng/mL
Standard Deviation 145000
|
—
|
313000 ng/mL
Standard Deviation 104000
|
473000 ng/mL
Standard Deviation 45300
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 29 Day 1
|
227000 ng/mL
Standard Deviation 218000
|
—
|
360000 ng/mL
Standard Deviation 108000
|
506000 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 35 Day 1
|
304000 ng/mL
Standard Deviation 63700
|
—
|
286000 ng/mL
Standard Deviation 137000
|
—
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 41 Day 1
|
282000 ng/mL
Standard Deviation 66500
|
—
|
434000 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 47 Day 1
|
257000 ng/mL
Standard Deviation 47400
|
—
|
283000 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Cmax of Total Antibody
Cycle 53 Day 1
|
—
|
—
|
281000 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFUPopulation: The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol \& had at least 1 evaluable posttreatment serum concentration of Total SN-38. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts \[Cohort 1 Group 1:NSCLC \[Adenocarcinoma + SCC\],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)\] were combined. The combined PK data was summarized \& reported.
Ctrough was defined as concentration at the end of the dosing interval of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=85 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=41 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=39 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=37 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
PK Parameter: Ctrough of Total SN-38
Cycle 1 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 2 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 3 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 7 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 11 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 17 Day 1
|
10.1 ng/mL
Standard Deviation 4.05
|
9.78 ng/mL
Standard Deviation 2.66
|
10.8 ng/mL
Standard Deviation 5.27
|
9.69 ng/mL
Standard Deviation 3.46
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 23 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
10.1 ng/mL
Standard Deviation 2.99
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 29 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
21.0 ng/mL
Standard Deviation 24.4
|
6.68 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 35 Day 1
|
7.00 ng/mL
Standard Deviation 1.78
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 41 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
6.61 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 47 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
6.12 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
Cycle 53 Day 1
|
—
|
—
|
7.55 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
EOT
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total SN-38
SFU
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
SECONDARY outcome
Timeframe: C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFUPopulation: The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol and had at least 1 evaluable posttreatment serum concentration of Free SN-38. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts \[Cohort 1 Group 1:NSCLC \[Adenocarcinoma + SCC\],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)\] were combined. The combined PK data was summarized \& reported.
Ctrough was defined as concentration at the end of the dosing interval of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=85 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=41 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=39 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=37 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
PK Parameter: Ctrough of Free SN-38
Cycle 1 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 2 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 3 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 7 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 11 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 17 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 23 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 29 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 35 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 41 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 47 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
Cycle 53 Day 1
|
—
|
—
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
EOT
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Free SN-38
SFU
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
SECONDARY outcome
Timeframe: C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFUPopulation: The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol \& had at least 1 evaluable posttreatment serum concentration of Total Antibody. Participants with available data were analyzed. As all participants were dosed with same dose of SG,the PK analysis for 3 NSCLC cohorts\[Cohort 1 Group 1:NSCLC \[Adenocarcinoma + SCC\],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)\] were combined. The combined PK data was summarized \& reported.
Ctrough was defined as concentration at the end of the dosing interval of total antibody of SG \[hRS7 immunoglobulin (IgG) and hRS7-SN-38\]. Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=78 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=41 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=35 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=36 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
PK Parameter: Ctrough of Total Antibody
Cycle 11 Day 1
|
97500 ng/mL
Standard Deviation 77400
|
169000 ng/mL
Standard Deviation 67700
|
86900 ng/mL
Standard Deviation 46800
|
81600 ng/mL
Standard Deviation 44300
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 17 Day 1
|
126000 ng/mL
Standard Deviation 61500
|
124000 ng/mL
Standard Deviation 57700
|
104000 ng/mL
Standard Deviation 58800
|
107000 ng/mL
Standard Deviation 20400
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 23 Day 1
|
80700 ng/mL
Standard Deviation 56000
|
—
|
58200 ng/mL
Standard Deviation 41700
|
97300 ng/mL
Standard Deviation 13800
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 29 Day 1
|
83400 ng/mL
Standard Deviation 42200
|
—
|
71100 ng/mL
Standard Deviation 4190082800
|
86100 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
SFU
|
33000 ng/mL
Standard Deviation 33300
|
23800 ng/mL
Standard Deviation 23000
|
45800 ng/mL
Standard Deviation 28800
|
18900 ng/mL
Standard Deviation 20800
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 1 Day 1
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
NA ng/mL
Standard Deviation NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 2 Day 1
|
35200 ng/mL
Standard Deviation 24900
|
52600 ng/mL
Standard Deviation 44300
|
46200 ng/mL
Standard Deviation 36100
|
36000 ng/mL
Standard Deviation 26500
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 3 Day 1
|
79500 ng/mL
Standard Deviation 58200
|
69000 ng/mL
Standard Deviation 40700
|
73500 ng/mL
Standard Deviation 49100
|
59500 ng/mL
Standard Deviation 49600
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 7 Day 1
|
89600 ng/mL
Standard Deviation 80400
|
70200 ng/mL
Standard Deviation 51600
|
107000 ng/mL
Standard Deviation 60800
|
65200 ng/mL
Standard Deviation 44800
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 35 Day 1
|
94800 ng/mL
Standard Deviation 17900
|
—
|
82800 ng/mL
Standard Deviation 105000
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 41 Day 1
|
39200 ng/mL
Standard Deviation 51600
|
—
|
2660 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 47 Day 1
|
42100 ng/mL
Standard Deviation 56200
|
—
|
2670 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
Cycle 53 Day 1
|
—
|
—
|
77200 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
PK Parameter: Ctrough of Total Antibody
EOT
|
54800 ng/mL
Standard Deviation 43100
|
64600 ng/mL
Standard Deviation 51500
|
62100 ng/mL
Standard Deviation 43800
|
56300 ng/mL
Standard Deviation 36900
|
—
|
—
|
SECONDARY outcome
Timeframe: C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFUPopulation: The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of SG and had at least 1 evaluable posttreatment anti-SG antibody test result.
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome measures
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=30 Participants
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=33 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=29 Participants
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 Participants
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 Participants
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 Participants
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-SG Antibodies
|
0 percentage of participants
|
3.0 percentage of participants
|
3.4 percentage of participants
|
4.7 percentage of participants
|
2.4 percentage of participants
|
4.7 percentage of participants
|
Adverse Events
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Serious events: 15 serious events
Other events: 30 other events
Deaths: 26 deaths
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Serious events: 11 serious events
Other events: 34 other events
Deaths: 27 deaths
Cohort 1 Group 3: NSCLC (SCC)
Serious events: 13 serious events
Other events: 30 other events
Deaths: 28 deaths
Cohort 2: HNSCC
Serious events: 13 serious events
Other events: 43 other events
Deaths: 35 deaths
Cohort 3: EC
Serious events: 19 serious events
Other events: 40 other events
Deaths: 30 deaths
Cohort 4: ES-SCLC
Serious events: 22 serious events
Other events: 43 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 participants at risk
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 participants at risk
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 participants at risk
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 participants at risk
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 participants at risk
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 participants at risk
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
17.1%
7/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Acute left ventricular failure
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Myopericarditis
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.2%
5/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Death
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Fatigue
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Pyrexia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Clostridium colitis
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Clostridium difficile colitis
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Covid-19
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Empyema
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Enterocolitis infectious
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Pneumonia aspiration
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Septic encephalopathy
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Septic shock
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Skin infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Haemorrhage intracranial
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Product Issues
Device dislocation
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Embolism
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Hypotension
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
Other adverse events
| Measure |
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
n=31 participants at risk
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
|
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
n=34 participants at risk
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
|
Cohort 1 Group 3: NSCLC (SCC)
n=31 participants at risk
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
|
Cohort 2: HNSCC
n=43 participants at risk
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
|
Cohort 3: EC
n=41 participants at risk
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
|
Cohort 4: ES-SCLC
n=43 participants at risk
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
35.5%
11/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
38.2%
13/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
35.5%
11/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
36.6%
15/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
41.9%
18/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.4%
6/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
23.5%
8/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
18.6%
8/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.6%
6/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Fatigue
|
48.4%
15/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
58.8%
20/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
58.1%
18/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
44.2%
19/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
58.5%
24/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
62.8%
27/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Neutropenia
|
51.6%
16/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
47.1%
16/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
48.4%
15/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
44.2%
19/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
58.5%
24/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
55.8%
24/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Cardiac disorders
Tachycardia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Eye disorders
Dry eye
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Eye disorders
Vision blurred
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
20.6%
7/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
18.6%
8/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Anemia
|
29.0%
9/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
35.3%
12/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
19.4%
6/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
30.2%
13/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
46.3%
19/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
30.2%
13/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Diarrhoea
|
67.7%
21/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
50.0%
17/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
48.4%
15/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
46.5%
20/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
53.7%
22/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
76.7%
33/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Nausea
|
38.7%
12/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
58.8%
20/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
38.7%
12/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
46.5%
20/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
56.1%
23/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
39.5%
17/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Stomatitis
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
17.6%
6/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.2%
5/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.3%
7/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
7/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
20.6%
7/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
22.6%
7/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
34.9%
15/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
24.4%
10/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
18.6%
8/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Chest pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Chills
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Oedema
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Oedema peripheral
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
17.6%
6/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.6%
6/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Peripheral swelling
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
General disorders
Pyrexia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.2%
5/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Bronchitis
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Covid-19
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
19.5%
8/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Herpes zoster
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
22.6%
7/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.8%
4/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
17.1%
7/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.2%
5/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Blood creatinine increased
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Blood potassium decreased
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Weight decreased
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.8%
4/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Investigations
Weight increased
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.8%
8/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
29.4%
10/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
35.5%
11/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
25.6%
11/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
23.3%
10/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
20.6%
7/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
19.4%
6/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.7%
5/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
17.1%
7/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
19.4%
6/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.3%
7/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
26.8%
11/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.3%
7/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.3%
7/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.8%
4/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
22.6%
7/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
17.1%
7/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.8%
4/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.7%
5/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Dysgeusia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.8%
4/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Headache
|
25.8%
8/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
23.5%
8/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
12.2%
5/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Paraesthesia
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Nervous system disorders
Taste disorder
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Psychiatric disorders
Depression
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Psychiatric disorders
Insomnia
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
20.6%
7/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.6%
6/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.8%
8/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
29.0%
9/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
25.6%
11/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.3%
3/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.2%
14/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
64.7%
22/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
41.9%
13/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
37.2%
16/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
41.5%
17/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
30.2%
13/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
8.8%
3/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.0%
6/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
14.6%
6/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
7.0%
3/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
4/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
19.5%
8/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
18.6%
8/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
5.9%
2/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.9%
2/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Flushing
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Hot flush
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.9%
1/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.7%
3/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.3%
1/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
4.7%
2/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Hypotension
|
19.4%
6/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.8%
4/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
16.1%
5/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
9.3%
4/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
2.4%
1/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
11.6%
5/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/34 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
6.5%
2/31 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/41 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
0.00%
0/43 • All-Cause Mortality and Adverse Events: Up to 5.3 years
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER