Trial Outcomes & Findings for A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT02521870)
NCT ID: NCT02521870
Last Updated: 2021-08-03
Results Overview
Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
241 participants
Primary outcome timeframe
Day 1 through Day 29
Results posted on
2021-08-03
Participant Flow
Participant milestones
| Measure |
SD-101 1 mg
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Dose Escalation
STARTED
|
6
|
5
|
5
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
Completed SD-101 Treatment (up to 11 Doses)
|
3
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
NOT COMPLETED
|
5
|
4
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2: Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
57
|
25
|
23
|
9
|
24
|
28
|
23
|
30
|
|
Phase 2: Dose Expansion
Completed SD-101 Treatment (up to 11 Doses)
|
0
|
0
|
0
|
0
|
25
|
7
|
3
|
2
|
9
|
5
|
1
|
11
|
|
Phase 2: Dose Expansion
Completed SD-101 Treatment Cycle 2 (up to 22 Doses)
|
0
|
0
|
0
|
0
|
7
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2: Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Phase 2: Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
52
|
25
|
23
|
9
|
22
|
28
|
23
|
30
|
Reasons for withdrawal
| Measure |
SD-101 1 mg
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Dose Escalation
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
Adverse Event
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
Progressive Disease
|
3
|
2
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2: Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
5
|
1
|
1
|
0
|
1
|
1
|
2
|
0
|
|
Phase 2: Dose Expansion
Adverse Event
|
0
|
0
|
0
|
0
|
11
|
2
|
0
|
1
|
5
|
0
|
1
|
0
|
|
Phase 2: Dose Expansion
Progressive Disease
|
0
|
0
|
0
|
0
|
22
|
18
|
17
|
7
|
5
|
17
|
17
|
21
|
|
Phase 2: Dose Expansion
Death
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
1
|
1
|
5
|
2
|
2
|
|
Phase 2: Dose Expansion
Other
|
0
|
0
|
0
|
0
|
10
|
3
|
2
|
0
|
10
|
5
|
1
|
7
|
|
Phase 2: Dose Expansion
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2: Dose Expansion
Non-Compliance with Study Drug
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg
n=45 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5.
|
Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg
n=41 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.
|
Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg
n=31 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8.
|
Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg
n=30 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.
|
HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg
n=28 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6.
|
HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg
n=23 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.
|
HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg
n=23 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7.
|
HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
n=9 Participants
Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
109 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
121 Participants
n=114 Participants
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 13.34 • n=99 Participants
|
65.3 years
STANDARD_DEVIATION 12.44 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 12.99 • n=206 Participants
|
62.4 years
STANDARD_DEVIATION 15.25 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 10.66 • n=31 Participants
|
67.2 years
STANDARD_DEVIATION 9.59 • n=30 Participants
|
61.0 years
STANDARD_DEVIATION 12.94 • n=3 Participants
|
65.2 years
STANDARD_DEVIATION 12.35 • n=6 Participants
|
64.4 years
STANDARD_DEVIATION 12.45 • n=114 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
64 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
166 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
20 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
212 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
212 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
|
ECOG Performance Status
0
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
110 Participants
n=114 Participants
|
|
ECOG Performance Status
1
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
120 Participants
n=114 Participants
|
|
PDL1 Expression
Positive
|
21 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
96 Participants
n=114 Participants
|
|
PDL1 Expression
Negative
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
60 Participants
n=114 Participants
|
|
PDL1 Expression
Unknown
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
74 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The safety population is defined as comprising of participants who received at least 1 dose of SD-101.
Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
Outcome measures
| Measure |
SD-101 1 mg
n=6 Participants
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
n=5 Participants
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
n=5 Participants
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
n=6 Participants
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation Only - Number of Participants With DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 743Population: The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.
Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Outcome measures
| Measure |
SD-101 1 mg
n=45 Participants
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
n=41 Participants
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
n=31 Participants
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
n=30 Participants
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
n=28 Participants
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
n=23 Participants
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
n=23 Participants
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
n=9 Participants
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Complete Response
|
9 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Partial Response
|
25 Participants
|
16 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Stable Disease
|
2 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Progressive Disease
|
5 Participants
|
8 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
Not Evaluable
|
4 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 743Population: The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response.
Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Outcome measures
| Measure |
SD-101 1 mg
n=34 Participants
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
n=20 Participants
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
n=7 Participants
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
n=4 Participants
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
n=6 Participants
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
n=6 Participants
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
n=2 Participants
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
n=1 Participants
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group
|
3.2 months
Standard Deviation 1.6
|
4.1 months
Standard Deviation 2.96
|
5.1 months
Standard Deviation 3.06
|
4.3 months
Standard Deviation 2.98
|
2.3 months
Standard Deviation .92
|
2.4 months
Standard Deviation 0.87
|
2.7 months
Standard Deviation 1.09
|
2.1 months
Standard Deviation 0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 743Population: The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response.
Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Outcome measures
| Measure |
SD-101 1 mg
n=34 Participants
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
n=20 Participants
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
n=7 Participants
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
n=4 Participants
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
n=6 Participants
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
n=6 Participants
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
n=2 Participants
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
n=1 Participants
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group
|
11.1 months
Standard Deviation 6.42
|
11.7 months
Standard Deviation 5.96
|
4.6 months
Standard Deviation 6.57
|
7.6 months
Standard Deviation 7.28
|
5.9 months
Standard Deviation 4.93
|
6.3 months
Standard Deviation 3.96
|
2.1 months
Standard Deviation 0.07
|
8.1 months
Standard Deviation 0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 743Population: The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.
Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Outcome measures
| Measure |
SD-101 1 mg
n=45 Participants
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
n=41 Participants
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
n=31 Participants
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
n=30 Participants
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
n=28 Participants
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
n=23 Participants
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
n=23 Participants
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
n=9 Participants
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group
|
36 Participants
|
28 Participants
|
15 Participants
|
12 Participants
|
13 Participants
|
11 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 743Population: The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study.
Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Outcome measures
| Measure |
SD-101 1 mg
n=45 Participants
Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg
n=41 Participants
Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 4 mg
n=31 Participants
Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg
n=30 Participants
Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma
n=28 Participants
Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma
n=23 Participants
Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC
n=23 Participants
Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC
n=9 Participants
Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma
Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC
Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC
Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
24 months
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
3 months
|
85.7 percentage of participants
Interval 70.9 to 93.3
|
71.9 percentage of participants
Interval 54.0 to 83.8
|
46.7 percentage of participants
Interval 28.4 to 63.0
|
48 percentage of participants
Interval 27.8 to 65.6
|
46.4 percentage of participants
Interval 26.6 to 64.1
|
43.5 percentage of participants
Interval 23.3 to 62.1
|
31.6 percentage of participants
Interval 12.9 to 52.2
|
37.5 percentage of participants
Interval 8.7 to 67.4
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
6 months
|
78.4 percentage of participants
Interval 62.6 to 88.1
|
63.3 percentage of participants
Interval 45.2 to 76.8
|
33 percentage of participants
Interval 17.2 to 49.8
|
24 percentage of participants
Interval 9.8 to 41.7
|
26.5 percentage of participants
Interval 10.5 to 45.7
|
17.4 percentage of participants
Interval 5.4 to 35.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
25 percentage of participants
Interval 3.7 to 55.8
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
9 months
|
70.8 percentage of participants
Interval 54.3 to 82.3
|
60.4 percentage of participants
Interval 42.4 to 74.4
|
21.4 percentage of participants
Interval 8.6 to 37.9
|
14.4 percentage of participants
Interval 3.9 to 31.4
|
21.2 percentage of participants
Interval 7.1 to 40.3
|
17.4 percentage of participants
Interval 5.4 to 35.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
12.5 percentage of participants
Interval 0.7 to 42.3
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
12 months
|
70.8 percentage of participants
Interval 54.3 to 82.3
|
53.7 percentage of participants
Interval 35.7 to 68.7
|
21.4 percentage of participants
Interval 8.6 to 37.9
|
9.6 percentage of participants
Interval 1.7 to 25.7
|
15.9 percentage of participants
Interval 4.2 to 34.4
|
8.7 percentage of participants
Interval 1.5 to 24.2
|
00 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
15 months
|
65.1 percentage of participants
Interval 48.2 to 77.8
|
49.9 percentage of participants
Interval 31.9 to 65.5
|
0 percentage of participants
Interval 0.0 to 0.0
|
9.6 percentage of participants
Interval 1.7 to 25.7
|
15.9 percentage of participants
Interval 4.2 to 34.4
|
4.3 percentage of participants
Interval 0.3 to 18.2
|
00 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
18 months
|
61.5 percentage of participants
Interval 44.0 to 75.0
|
40.3 percentage of participants
Interval 22.3 to 57.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
9.6 percentage of participants
Interval 1.7 to 25.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group
21 months
|
61.5 percentage of participants
Interval 44.0 to 75.0
|
40.3 percentage of participants
Interval 22.3 to 57.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
Adverse Events
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg
Serious events: 15 serious events
Other events: 44 other events
Deaths: 2 deaths
Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg
Serious events: 17 serious events
Other events: 39 other events
Deaths: 3 deaths
Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg
Serious events: 6 serious events
Other events: 31 other events
Deaths: 5 deaths
Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg
Serious events: 9 serious events
Other events: 30 other events
Deaths: 7 deaths
HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg
Serious events: 8 serious events
Other events: 25 other events
Deaths: 6 deaths
HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg
Serious events: 5 serious events
Other events: 23 other events
Deaths: 13 deaths
HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg
Serious events: 10 serious events
Other events: 22 other events
Deaths: 7 deaths
HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg
n=44 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 5.
|
Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg
n=39 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.
|
Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg
n=31 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 8.
|
Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg
n=30 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.
|
HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg
n=27 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 6.
|
HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg
n=23 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.
|
HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg
n=23 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion and Cohort 7.
|
HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
n=9 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Cellulitis
|
4.5%
2/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Erysipelas
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Gastroenteritis
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Influenza
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Sepsis
|
4.5%
2/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Septic shock
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Skin infection
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Eye disorders
Autoimmune retinopathy
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Asthenia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Generalised oedema
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Influenza like illness
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Localised oedema
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Oedema peripheral
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Pyrexia
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Endocrine disorders
Hypophysitis
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Urosepsis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Blood creatinine increased
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Embolic stroke
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Parkinson's disease
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Seizure
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Syncope
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Psychiatric disorders
Violence-related symptom
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Hypotension
|
0.00%
0/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
Other adverse events
| Measure |
Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg
n=44 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 5.
|
Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg
n=39 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1.
|
Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg
n=31 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 8.
|
Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg
n=30 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2.
|
HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg
n=27 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 6.
|
HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg
n=23 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3.
|
HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg
n=23 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion and Cohort 7.
|
HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
n=9 participants at risk
Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses.
The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.5%
2/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
2/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.4%
5/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
11.1%
3/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Anaemia
|
15.9%
7/44 • From informed consent through Day 743
|
25.6%
10/39 • From informed consent through Day 743
|
12.9%
4/31 • From informed consent through Day 743
|
13.3%
4/30 • From informed consent through Day 743
|
14.8%
4/27 • From informed consent through Day 743
|
21.7%
5/23 • From informed consent through Day 743
|
13.0%
3/23 • From informed consent through Day 743
|
22.2%
2/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
11/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Eye disorders
Dry eye
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Eye disorders
Vision blurred
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Constipation
|
18.2%
8/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
20.0%
6/30 • From informed consent through Day 743
|
14.8%
4/27 • From informed consent through Day 743
|
17.4%
4/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Diarrhoea
|
47.7%
21/44 • From informed consent through Day 743
|
28.2%
11/39 • From informed consent through Day 743
|
19.4%
6/31 • From informed consent through Day 743
|
23.3%
7/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
30.4%
7/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
2/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
18.5%
5/27 • From informed consent through Day 743
|
26.1%
6/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Nausea
|
29.5%
13/44 • From informed consent through Day 743
|
38.5%
15/39 • From informed consent through Day 743
|
29.0%
9/31 • From informed consent through Day 743
|
33.3%
10/30 • From informed consent through Day 743
|
29.6%
8/27 • From informed consent through Day 743
|
34.8%
8/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Stomatitis
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
6/44 • From informed consent through Day 743
|
15.4%
6/39 • From informed consent through Day 743
|
19.4%
6/31 • From informed consent through Day 743
|
20.0%
6/30 • From informed consent through Day 743
|
18.5%
5/27 • From informed consent through Day 743
|
13.0%
3/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Asthenia
|
4.5%
2/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Chest pain
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Chills
|
43.2%
19/44 • From informed consent through Day 743
|
51.3%
20/39 • From informed consent through Day 743
|
19.4%
6/31 • From informed consent through Day 743
|
53.3%
16/30 • From informed consent through Day 743
|
11.1%
3/27 • From informed consent through Day 743
|
43.5%
10/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
General disorders
Face oedema
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Fatigue
|
75.0%
33/44 • From informed consent through Day 743
|
79.5%
31/39 • From informed consent through Day 743
|
41.9%
13/31 • From informed consent through Day 743
|
73.3%
22/30 • From informed consent through Day 743
|
55.6%
15/27 • From informed consent through Day 743
|
73.9%
17/23 • From informed consent through Day 743
|
30.4%
7/23 • From informed consent through Day 743
|
55.6%
5/9 • From informed consent through Day 743
|
|
General disorders
Gait disturbance
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Influenza like illness
|
29.5%
13/44 • From informed consent through Day 743
|
17.9%
7/39 • From informed consent through Day 743
|
32.3%
10/31 • From informed consent through Day 743
|
13.3%
4/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Injection site erythema
|
38.6%
17/44 • From informed consent through Day 743
|
23.1%
9/39 • From informed consent through Day 743
|
12.9%
4/31 • From informed consent through Day 743
|
43.3%
13/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
17.4%
4/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
General disorders
Injection site induration
|
2.3%
1/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Injection site pain
|
25.0%
11/44 • From informed consent through Day 743
|
15.4%
6/39 • From informed consent through Day 743
|
12.9%
4/31 • From informed consent through Day 743
|
26.7%
8/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
General disorders
Injection site pruritus
|
6.8%
3/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Injection site reaction
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Injection site swelling
|
20.5%
9/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
13.0%
3/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
General disorders
Malaise
|
31.8%
14/44 • From informed consent through Day 743
|
51.3%
20/39 • From informed consent through Day 743
|
12.9%
4/31 • From informed consent through Day 743
|
36.7%
11/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
22.2%
2/9 • From informed consent through Day 743
|
|
General disorders
Non-cardiac chest pain
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Oedema peripheral
|
9.1%
4/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Pain
|
11.4%
5/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
General disorders
Pyrexia
|
22.7%
10/44 • From informed consent through Day 743
|
38.5%
15/39 • From informed consent through Day 743
|
22.6%
7/31 • From informed consent through Day 743
|
23.3%
7/30 • From informed consent through Day 743
|
22.2%
6/27 • From informed consent through Day 743
|
26.1%
6/23 • From informed consent through Day 743
|
26.1%
6/23 • From informed consent through Day 743
|
44.4%
4/9 • From informed consent through Day 743
|
|
General disorders
Secretion discharge
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Infections and infestations
Candida infection
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Cellulitis
|
11.4%
5/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Folliculitis
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Gastroenteritis viral
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Oral candidiasis
|
6.8%
3/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Sinusitis
|
4.5%
2/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Skin infection
|
6.8%
3/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
5/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Infections and infestations
Urinary tract infection
|
9.1%
4/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
4/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
6/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
13.3%
4/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Blood alkaline phosphatase increased
|
6.8%
3/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Blood creatinine increased
|
15.9%
7/44 • From informed consent through Day 743
|
20.5%
8/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
C-reactive protein increased
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Lymphocyte count decreased
|
2.3%
1/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Neutrophil count decreased
|
4.5%
2/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Platelet count decreased
|
6.8%
3/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
Weight decreased
|
6.8%
3/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Investigations
White blood cell count decreased
|
6.8%
3/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
11/44 • From informed consent through Day 743
|
28.2%
11/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
30.0%
9/30 • From informed consent through Day 743
|
11.1%
3/27 • From informed consent through Day 743
|
13.0%
3/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
4/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.4%
16/44 • From informed consent through Day 743
|
20.5%
8/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
13.3%
4/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
4/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
2/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.9%
18/44 • From informed consent through Day 743
|
43.6%
17/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
53.3%
16/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
39.1%
9/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
22.2%
2/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
22.2%
2/9 • From informed consent through Day 743
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
4/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.8%
3/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
12.9%
4/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
14.8%
4/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Dizziness
|
15.9%
7/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
13.3%
4/30 • From informed consent through Day 743
|
18.5%
5/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Dysaesthesia
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Dysgeusia
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Headache
|
52.3%
23/44 • From informed consent through Day 743
|
64.1%
25/39 • From informed consent through Day 743
|
29.0%
9/31 • From informed consent through Day 743
|
46.7%
14/30 • From informed consent through Day 743
|
11.1%
3/27 • From informed consent through Day 743
|
43.5%
10/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
44.4%
4/9 • From informed consent through Day 743
|
|
Nervous system disorders
Hypoaesthesia
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Paraesthesia
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Presyncope
|
4.5%
2/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Sinus headache
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Somnolence
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Nervous system disorders
Tremor
|
2.3%
1/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
13.0%
3/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
22.2%
2/9 • From informed consent through Day 743
|
|
Psychiatric disorders
Insomnia
|
9.1%
4/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
11.1%
3/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
8/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
20.0%
6/30 • From informed consent through Day 743
|
11.1%
3/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
22.2%
2/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.4%
5/44 • From informed consent through Day 743
|
23.1%
9/39 • From informed consent through Day 743
|
19.4%
6/31 • From informed consent through Day 743
|
13.3%
4/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
6.5%
2/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
4/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
2/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
3/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.8%
3/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.4%
5/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
12.9%
4/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.8%
3/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/44 • From informed consent through Day 743
|
0.00%
0/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.8%
14/44 • From informed consent through Day 743
|
15.4%
6/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
23.3%
7/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
17.4%
4/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
11/44 • From informed consent through Day 743
|
17.9%
7/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.3%
1/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.4%
5/44 • From informed consent through Day 743
|
12.8%
5/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
10.0%
3/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.8%
3/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Scab
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.3%
1/44 • From informed consent through Day 743
|
7.7%
3/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
11.4%
5/44 • From informed consent through Day 743
|
10.3%
4/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Flushing
|
4.5%
2/44 • From informed consent through Day 743
|
5.1%
2/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Haematoma
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Hypertension
|
9.1%
4/44 • From informed consent through Day 743
|
33.3%
13/39 • From informed consent through Day 743
|
3.2%
1/31 • From informed consent through Day 743
|
6.7%
2/30 • From informed consent through Day 743
|
3.7%
1/27 • From informed consent through Day 743
|
8.7%
2/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
|
Vascular disorders
Hypotension
|
2.3%
1/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
0.00%
0/31 • From informed consent through Day 743
|
0.00%
0/30 • From informed consent through Day 743
|
7.4%
2/27 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
4.3%
1/23 • From informed consent through Day 743
|
11.1%
1/9 • From informed consent through Day 743
|
|
Vascular disorders
Lymphoedema
|
4.5%
2/44 • From informed consent through Day 743
|
2.6%
1/39 • From informed consent through Day 743
|
9.7%
3/31 • From informed consent through Day 743
|
3.3%
1/30 • From informed consent through Day 743
|
0.00%
0/27 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/23 • From informed consent through Day 743
|
0.00%
0/9 • From informed consent through Day 743
|
Additional Information
Robert Janssen MD \ VP & Chief Medical Officer
Dynavax Technologies, Inc.
Phone: 510-665-0414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60