Trial Outcomes & Findings for INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP) (NCT NCT04398433)
NCT ID: NCT04398433
Last Updated: 2026-04-14
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From first dose of study drug through 30 days following the last dose (approximately up to Week 13)
Results posted on
2026-04-14
Participant Flow
Participants were enrolled in this study from 07 October 2020 to 15 December 2022. Data for all participants, including those in the safety run-in, is included in the reported arms.
A total of 32 participants with recurrent respiratory papillomatosis (RRP) were enrolled and treated in this study.
Participant milestones
| Measure |
INO-3107: Group 1
Participants who had less than or equal to (≤) 2 surgeries received 6.25 milligrams per milliliter (mg/mL) INO-3107, intramuscular (IM) injection, followed by electroporation (EP) using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
Participants who had more than or equal to (≥) 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
18
|
8
|
|
Overall Study
COMPLETED
|
6
|
18
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
Baseline characteristics by cohort
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 8.87 • n=193 Participants
|
49.2 years
STANDARD_DEVIATION 13.08 • n=193 Participants
|
50.4 years
STANDARD_DEVIATION 21.06 • n=386 Participants
|
47.3 years
STANDARD_DEVIATION 15.18 • n=112 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
8 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=193 Participants
|
14 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
24 Participants
n=112 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
3 Participants
n=112 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=193 Participants
|
16 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
29 Participants
n=112 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
4 Participants
n=112 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=193 Participants
|
16 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
26 Participants
n=112 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days following the last dose (approximately up to Week 13)Population: The safety population included all participants who had received at least one dose of INO-3107. Percentages are rounded off to the nearest decimal point.
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Percentage of Participants with Serious TEAEs
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Percentage of Participants with TEAEs
|
33.3 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The mITT population included all participants who had received at least one dose of INO-3107.
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Change in Number of Recurrent Respiratory Papillomatosis (RRP) Surgical Interventions in One Year Following Day 0, Compared to One Year Prior to Day 0
|
-1.0 Number of surgical interventions
Interval -2.0 to 1.0
|
-3.0 Number of surgical interventions
Interval -3.0 to -2.0
|
-3.5 Number of surgical interventions
Interval -6.0 to -2.0
|
-3.0 Number of surgical interventions
Interval -3.0 to -2.0
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The mITT population included all participants who had received at least one dose of INO-3107. Percentages are rounded off to the nearest decimal point.
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
25% to < 50% Reduction in Post Surgeries
|
0 percentage of participants
|
5.6 percentage of participants
|
25.0 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
100% Reduction in Post Surgeries
|
33.3 percentage of participants
|
33.3 percentage of participants
|
12.5 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
75% to less than (<)100% Reduction in Post Surgeries
|
0 percentage of participants
|
22.2 percentage of participants
|
12.5 percentage of participants
|
15.6 percentage of participants
|
|
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
50% to < 75% Reduction in Post Surgeries
|
33.3 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
Greater than (>)0% to < 25% Reduction in Post Surgeries
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year
Less than or equal to (≤) 0% Reduction in Post Surgeries
|
33.3 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 11, 26, and 52Population: The mITT population included all participants who had received at least one dose of INO-3107. "Number analyzed" are the number of participants with data available at the specified timepoint.
RRP staging assessment score was determined using a modified Derkay staging tool. It included both a subjective functional assessment of clinical parameters and an anatomic assessment of disease distribution. The anatomic score was then used in combination with the functional score to measure an individual participant's clinical course and response to the therapy over time. The score ranges from 0-179, where a higher score indicates worse disease. Baseline is defined as the most recent measurement prior to the first (Day 0) dose. Total Site Score + Total Symptom Score = Total Clinical Score.
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Change From Baseline in RRP Staging Assessment Scores Over Time
Change at Week 6
|
-7.5 score on a scale
Interval -17.9 to 2.9
|
-15.4 score on a scale
Interval -26.0 to -4.8
|
-15.6 score on a scale
Interval -31.1 to -0.1
|
-13.9 score on a scale
Interval -20.6 to -7.2
|
|
Change From Baseline in RRP Staging Assessment Scores Over Time
Change at Week 11
|
-8.2 score on a scale
Interval -20.0 to 3.7
|
-14.7 score on a scale
Interval -24.0 to -5.3
|
-15.1 score on a scale
Interval -31.8 to 1.5
|
-13.6 score on a scale
Interval -19.9 to -7.2
|
|
Change From Baseline in RRP Staging Assessment Scores Over Time
Change at Week 26
|
-8.2 score on a scale
Interval -18.9 to 2.6
|
-12.8 score on a scale
Interval -21.2 to -4.4
|
-16.8 score on a scale
Interval -32.2 to -1.3
|
-12.9 score on a scale
Interval -18.7 to -7.1
|
|
Change From Baseline in RRP Staging Assessment Scores Over Time
Change at Week 52
|
-6.3 score on a scale
Interval -14.6 to 2.0
|
-10.7 score on a scale
Interval -19.0 to -2.3
|
-15.4 score on a scale
Interval -30.5 to -0.3
|
-11.0 score on a scale
Interval -16.7 to -5.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 9, 11, 26, and 52Population: The mITT population included all participants who had received at least one dose of INO-3107. "Number analyzed" are the number of participants with data available at the specified timepoint.
Whole blood samples were collected and PBMCs were isolated to be tested for T-lymphocytes producing interferon-gamma (IFN-γ) in response to the human papilloma virus (HPV) types 6E6+6E7, and 11E6+11E7 antigens. The antigen-specific cellular immune response to INO-3107 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10\^6, PBMC) using ELISpot for this outcome measure (OM).
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 6E6+6E7: Week 11
|
15.000 SFU/10^6, PBMC
Interval 0.0 to 75.0
|
11.667 SFU/10^6, PBMC
Interval 0.0 to 430.83
|
18.333 SFU/10^6, PBMC
Interval 0.0 to 53.33
|
15.833 SFU/10^6, PBMC
Interval 0.0 to 430.83
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 11E6+11E7: Week 6
|
9.167 SFU/10^6, PBMC
Interval 1.67 to 35.0
|
1.667 SFU/10^6, PBMC
Interval 0.0 to 111.67
|
8.333 SFU/10^6, PBMC
Interval 0.0 to 65.0
|
3.333 SFU/10^6, PBMC
Interval 0.0 to 111.67
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 11E6+11E7: Week 52
|
16.667 SFU/10^6, PBMC
Interval 5.0 to 50.0
|
11.667 SFU/10^6, PBMC
Interval 0.0 to 2283.33
|
21.667 SFU/10^6, PBMC
Interval 5.0 to 78.33
|
16.667 SFU/10^6, PBMC
Interval 0.0 to 2283.33
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 6E6+6E7: Baseline
|
4.500 SFU/10^6, PBMC
Interval 2.0 to 11.67
|
3.667 SFU/10^6, PBMC
Interval 0.67 to 485.0
|
4.500 SFU/10^6, PBMC
Interval 0.67 to 20.0
|
3.667 SFU/10^6, PBMC
Interval 0.67 to 485.0
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 6E6+6E7: Week 6
|
7.500 SFU/10^6, PBMC
Interval 0.0 to 30.0
|
1.667 SFU/10^6, PBMC
Interval 0.0 to 111.67
|
11.667 SFU/10^6, PBMC
Interval 0.0 to 38.33
|
5.000 SFU/10^6, PBMC
Interval 0.0 to 111.67
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 6E6+6E7: Week 9
|
7.500 SFU/10^6, PBMC
Interval 1.67 to 48.33
|
10.000 SFU/10^6, PBMC
Interval 0.0 to 840.0
|
11.667 SFU/10^6, PBMC
Interval 5.0 to 30.0
|
11.667 SFU/10^6, PBMC
Interval 0.0 to 840.0
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 6E6+6E7: Week 26
|
1.667 SFU/10^6, PBMC
Interval 0.0 to 23.33
|
7.500 SFU/10^6, PBMC
Interval 0.0 to 311.67
|
28.333 SFU/10^6, PBMC
Interval 0.0 to 156.67
|
9.167 SFU/10^6, PBMC
Interval 0.0 to 311.67
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 6E6+6E7: Week 52
|
5.833 SFU/10^6, PBMC
Interval 0.0 to 23.33
|
5.833 SFU/10^6, PBMC
Interval 0.0 to 681.67
|
13.333 SFU/10^6, PBMC
Interval 6.67 to 60.0
|
10.000 SFU/10^6, PBMC
Interval 0.0 to 681.67
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 11E6+11E7: Baseline
|
5.000 SFU/10^6, PBMC
Interval 0.67 to 15.0
|
4.333 SFU/10^6, PBMC
Interval 0.67 to 1020.0
|
2.000 SFU/10^6, PBMC
Interval 0.67 to 22.0
|
4.333 SFU/10^6, PBMC
Interval 0.67 to 1020.0
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 11E6+11E7: Week 9
|
10.833 SFU/10^6, PBMC
Interval 5.0 to 48.33
|
15.000 SFU/10^6, PBMC
Interval 0.0 to 1516.67
|
15.000 SFU/10^6, PBMC
Interval 0.0 to 46.67
|
15.000 SFU/10^6, PBMC
Interval 0.0 to 1516.67
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 11E6+11E7: Week 11
|
13.333 SFU/10^6, PBMC
Interval 3.33 to 135.0
|
17.500 SFU/10^6, PBMC
Interval 0.0 to 838.33
|
43.333 SFU/10^6, PBMC
Interval 0.0 to 75.0
|
20.833 SFU/10^6, PBMC
Interval 0.0 to 838.33
|
|
Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)
HPV 11E6+11E7: Week 26
|
1.667 SFU/10^6, PBMC
Interval 1.667 to 48.33
|
6.667 SFU/10^6, PBMC
Interval 0.0 to 513.33
|
45.000 SFU/10^6, PBMC
Interval 15.0 to 176.67
|
16.250 SFU/10^6, PBMC
Interval 0.0 to 513.33
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 9, 11, 26, and 52Population: The mITT population included all participants who had received at least one dose of INO-3107. "Number analyzed" are the number of participants with data available at the specified timepoint.
Cellular immune activity was measured using flow cytometry for the purposes of performing a lytic granule loading assay, which analyzed the intracellular markers involved in lytic degranulation and cytotoxic potential: Granzyme A (GrzA), Granzyme B (GrzB), Granulysin, and Perforin (Prf). Subtypes of CD8 T-cells: CD8 HPV-6 CD38+GrzA+GrzB+Prf+, CD8 HPV-11 CD38+GrzA+GrzB+Prf+, CD8 HPV-6 Ki67+GrzA+GrzB+Prf+, and CD8 HPV-11 Ki67+GrzA+GrzB+Prf+, subtypes of CD4 T-cells - CD4 HPV-6 CD38+, CD4 HPV-11 CD38+, CD4 HPV-6 Ki67+, and CD4 HPV-11 Ki67+ are reported.
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 CD38+: Week 9
|
0.1754 percentage of cells
Interval 0.0 to 0.621
|
0.5044 percentage of cells
Interval 0.0 to 2.882
|
0.0656 percentage of cells
Interval 0.0 to 1.042
|
0.2158 percentage of cells
Interval 0.0 to 2.882
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 CD38+: Week 11
|
0.1503 percentage of cells
Interval 0.0 to 0.924
|
0.9483 percentage of cells
Interval 0.0 to 4.54
|
0.1484 percentage of cells
Interval 0.0 to 2.655
|
0.4087 percentage of cells
Interval 0.0 to 4.54
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 Ki67+: Week 11
|
0.1959 percentage of cells
Interval 0.0 to 0.427
|
0.0168 percentage of cells
Interval 0.0 to 2.249
|
0 percentage of cells
Interval 0.0 to 0.942
|
0.0168 percentage of cells
Interval 0.0 to 2.249
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 Ki67+: Week 9
|
0.0859 percentage of cells
Interval 0.0 to 0.445
|
0.2508 percentage of cells
Interval 0.0 to 3.258
|
0.0971 percentage of cells
Interval 0.0 to 0.387
|
0.1719 percentage of cells
Interval 0.0 to 3.258
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 Ki67+GrzA+GrzB+Prf+: Week 11
|
0.17146 percentage of cells
Interval 0.072 to 0.6228
|
0.18766 percentage of cells
Interval 0.0 to 12.5987
|
0.34671 percentage of cells
Interval 0.0091 to 0.8429
|
0.18486 percentage of cells
Interval 0.0 to 12.5987
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 Ki67+GrzA+GrzB+Prf+: Week 26
|
0.18531 percentage of cells
Interval 0.0 to 0.498
|
0.09248 percentage of cells
Interval 0.0 to 6.4803
|
0.32772 percentage of cells
Interval 0.0 to 4.7817
|
0.1904 percentage of cells
Interval 0.0 to 6.4803
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 CD38+: Baseline
|
0 percentage of cells
Interval 0.0 to 1.412
|
0.0819 percentage of cells
Interval 0.0 to 1.331
|
0.2033 percentage of cells
Interval 0.0 to 1.131
|
0.0819 percentage of cells
Interval 0.0 to 1.412
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 CD38+: Week 6
|
0 percentage of cells
Interval 0.0 to 0.894
|
0 percentage of cells
Interval 0.0 to 1.725
|
0 percentage of cells
Interval 0.0 to 0.34
|
0 percentage of cells
Interval 0.0 to 1.725
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 CD38+: Week 11
|
0.0843 percentage of cells
Interval 0.0 to 0.412
|
0.2255 percentage of cells
Interval 0.0 to 2.128
|
0 percentage of cells
Interval 0.0 to 1.279
|
0.1385 percentage of cells
Interval 0.0 to 2.128
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 CD38+: Week 26
|
0 percentage of cells
Interval 0.0 to 0.0
|
0 percentage of cells
Interval 0.0 to 1.808
|
0.4635 percentage of cells
Interval 0.0 to 1.417
|
0 percentage of cells
Interval 0.0 to 1.808
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 CD38+: Baseline
|
0.1022 percentage of cells
Interval 0.0 to 0.696
|
0.0633 percentage of cells
Interval 0.0 to 2.572
|
0.1737 percentage of cells
Interval 0.0 to 1.301
|
0.0748 percentage of cells
Interval 0.0 to 2.572
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 CD38+: Week 6
|
0.1827 percentage of cells
Interval 0.0 to 0.835
|
0.2503 percentage of cells
Interval 0.0 to 2.176
|
0.1466 percentage of cells
Interval 0.0 to 1.252
|
0.1828 percentage of cells
Interval 0.0 to 2.176
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 Ki67+: Week 11
|
0.1927 percentage of cells
Interval 0.0 to 1.107
|
0.2641 percentage of cells
Interval 0.0 to 3.794
|
0.3520 percentage of cells
Interval 0.0 to 1.865
|
0.2123 percentage of cells
Interval 0.0 to 3.794
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 Ki67+GrzA+GrzB+Prf+: Week 9
|
0.17603 percentage of cells
Interval 0.0 to 0.4721
|
0.24434 percentage of cells
Interval 0.0 to 9.7197
|
0.21158 percentage of cells
Interval 0.0 to 0.4708
|
0.2156 percentage of cells
Interval 0.0 to 9.7197
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 CD38+GrzA+GrzB+Prf+: Week 6
|
0 percentage of cells
Interval 0.0 to 0.0767
|
0.04288 percentage of cells
Interval 0.0 to 1.2633
|
0.00162 percentage of cells
Interval 0.0 to 1.1177
|
0.00018 percentage of cells
Interval 0.0 to 1.2633
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 CD38+GrzA+GrzB+Prf+: Week 9
|
0.32964 percentage of cells
Interval 0.0 to 0.8921
|
0.22409 percentage of cells
Interval 0.0 to 7.4466
|
0.03817 percentage of cells
Interval 0.0 to 0.2312
|
0.20278 percentage of cells
Interval 0.0 to 7.4466
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 CD38+GrzA+GrzB+Prf+: Week 11
|
0.12111 percentage of cells
Interval 0.0 to 0.9553
|
0.1586 percentage of cells
Interval 0.0 to 8.4276
|
0.02799 percentage of cells
Interval 0.0 to 2.2882
|
0.12105 percentage of cells
Interval 0.0 to 8.4276
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 CD38+GrzA+GrzB+Prf+: Week 26
|
0 percentage of cells
Interval 0.0 to 0.2649
|
0 percentage of cells
Interval 0.0 to 5.0262
|
0.41511 percentage of cells
Interval 0.186 to 1.5286
|
0.07064 percentage of cells
Interval 0.0 to 5.0262
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 CD38+GrzA+GrzB+Prf+: Week 52
|
0 percentage of cells
Interval 0.0 to 0.0945
|
0 percentage of cells
Interval 0.0 to 4.6878
|
0.29803 percentage of cells
Interval 0.0 to 1.1137
|
0 percentage of cells
Interval 0.0 to 4.6878
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 CD38+: Week 26
|
0 percentage of cells
Interval 0.0 to 0.212
|
0.4138 percentage of cells
Interval 0.0 to 2.819
|
0.8403 percentage of cells
Interval 0.0 to 2.151
|
0.3345 percentage of cells
Interval 0.0 to 2.819
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 CD38+GrzA+GrzB+Prf+: Baseline
|
0.05829 percentage of cells
Interval 0.0 to 0.4364
|
0.08991 percentage of cells
Interval 0.0 to 3.7699
|
0.31804 percentage of cells
Interval 0.0 to 2.1766
|
0.10455 percentage of cells
Interval 0.0 to 3.7699
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 Ki67+GrzA+GrzB+Prf+: Week 11
|
0.0371 percentage of cells
Interval 0.0 to 0.603
|
0.07391 percentage of cells
Interval 0.0 to 5.4808
|
0.0304 percentage of cells
Interval 0.0 to 0.6839
|
0.0653 percentage of cells
Interval 0.0 to 5.4808
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 Ki67+GrzA+GrzB+Prf+: Week 26
|
0.05905 percentage of cells
Interval 0.0 to 0.3282
|
0.01041 percentage of cells
Interval 0.0 to 3.7623
|
0.23824 percentage of cells
Interval 0.0 to 1.4732
|
0.07705 percentage of cells
Interval 0.0 to 3.7623
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 Ki67+GrzA+GrzB+Prf+: Week 52
|
0.10519 percentage of cells
Interval 0.0 to 0.2831
|
0.01103 percentage of cells
Interval 0.0 to 3.4775
|
0.32676 percentage of cells
Interval 0.0 to 1.0973
|
0.04629 percentage of cells
Interval 0.0 to 3.4775
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 Ki67+GrzA+GrzB+Prf: Baseline
|
0.2013 percentage of cells
Interval 0.0 to 1.9987
|
0.0698 percentage of cells
Interval 0.0 to 5.0131
|
0.08558 percentage of cells
Interval 0.0037 to 0.9188
|
0.08583 percentage of cells
Interval 0.0 to 5.0131
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 Ki67+GrzA+GrzB+Prf+: Week 6
|
0.02794 percentage of cells
Interval 0.0 to 0.1605
|
0.04422 percentage of cells
Interval 0.0 to 0.6615
|
0.19911 percentage of cells
Interval 0.0 to 1.6968
|
0.05578 percentage of cells
Interval 0.0 to 1.6968
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 CD38+GrzA+GrzB+Prf+: Baseline
|
0.25633 percentage of cells
Interval 0.1551 to 2.0711
|
0.265 percentage of cells
Interval 0.0 to 7.9903
|
0.23843 percentage of cells
Interval 0.0167 to 0.9397
|
0.23843 percentage of cells
Interval 0.0 to 7.9903
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 CD38+GrzA+GrzB+Prf+: Week 6
|
0 percentage of cells
Interval 0.0 to 0.6841
|
0.11976 percentage of cells
Interval 0.0 to 1.7898
|
0.38791 percentage of cells
Interval 0.0 to 4.0127
|
0.1226 percentage of cells
Interval 0.0 to 4.0127
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 CD38+GrzA+GrzB+Prf+: Week 9
|
0.26993 percentage of cells
Interval 0.0 to 1.0108
|
0.0629 percentage of cells
Interval 0.0 to 13.7727
|
0.42515 percentage of cells
Interval 0.0103 to 0.7583
|
0.30881 percentage of cells
Interval 0.0 to 13.7727
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 CD38+GrzA+GrzB+Prf+: Week 11
|
0.30238 percentage of cells
Interval 0.0 to 0.4332
|
0.46607 percentage of cells
Interval 0.0 to 19.3706
|
0.62558 percentage of cells
Interval 0.0 to 2.7857
|
0.40793 percentage of cells
Interval 0.0 to 19.3706
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 CD38+GrzA+GrzB+Prf+: Week 26
|
0.03132 percentage of cells
Interval 0.0 to 0.5152
|
0.05262 percentage of cells
Interval 0.0 to 9.8557
|
0.77653 percentage of cells
Interval 0.0 to 5.2246
|
0.23212 percentage of cells
Interval 0.0 to 9.8557
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 CD38+GrzA+GrzB+Prf+: Week 52
|
0.00906 percentage of cells
Interval 0.0 to 0.7485
|
0.62456 percentage of cells
Interval 0.0 to 15.9901
|
0.87978 percentage of cells
Interval 0.0112 to 3.2755
|
0.17493 percentage of cells
Interval 0.0 to 15.9901
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 Ki67+GrzA+GrzB+Prf+: Baseline
|
0.07275 percentage of cells
Interval 0.0 to 0.5166
|
0.02727 percentage of cells
Interval 0.0 to 2.8244
|
0.09713 percentage of cells
Interval 0.0 to 0.8693
|
0.03865 percentage of cells
Interval 0.0 to 2.8244
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 Ki67+GrzA+GrzB+Prf+: Week 6
|
0.01961 percentage of cells
Interval 0.0 to 0.1132
|
0 percentage of cells
Interval 0.0 to 0.2119
|
0.05988 percentage of cells
Interval 0.0 to 0.5495
|
0.00854 percentage of cells
Interval 0.0 to 0.5495
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-6 Ki67+GrzA+GrzB+Prf+: Week 9
|
0.09954 percentage of cells
Interval 0.0173 to 0.4651
|
0.04494 percentage of cells
Interval 0.0 to 6.2981
|
0.01175 percentage of cells
Interval 0.0 to 0.1128
|
0.04619 percentage of cells
Interval 0.0 to 6.2981
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 Ki67+: Week 52
|
0.1132 percentage of cells
Interval 0.0 to 1.09
|
0.0433 percentage of cells
Interval 0.0 to 1.377
|
0.4484 percentage of cells
Interval 0.0 to 2.887
|
0.1116 percentage of cells
Interval 0.0 to 2.887
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 Ki67+: Week 26
|
0 percentage of cells
Interval 0.0 to 0.105
|
0.2792 percentage of cells
Interval 0.0 to 2.017
|
0.2476 percentage of cells
Interval 0.0 to 1.459
|
0.1047 percentage of cells
Interval 0.0 to 2.017
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 Ki67+: Week 52
|
0 percentage of cells
Interval 0.0 to 1.27
|
0.0027 percentage of cells
Interval 0.0 to 1.012
|
0.5257 percentage of cells
Interval 0.0 to 1.178
|
0.0027 percentage of cells
Interval 0.0 to 1.27
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 Ki67+: Baseline
|
0.0091 percentage of cells
Interval 0.0 to 0.118
|
0.0804 percentage of cells
Interval 0.0 to 2.558
|
0.1879 percentage of cells
Interval 0.0 to 0.889
|
0.0690 percentage of cells
Interval 0.0 to 2.558
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 Ki67+: Week 6
|
0.0597 percentage of cells
Interval 0.0 to 0.634
|
0.0753 percentage of cells
Interval 0.0 to 2.364
|
0.1344 percentage of cells
Interval 0.0 to 1.198
|
0.0788 percentage of cells
Interval 0.0 to 2.364
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 Ki67+: Week 26
|
0 percentage of cells
Interval 0.0 to 0.415
|
0.3982 percentage of cells
Interval 0.0 to 2.815
|
0.3022 percentage of cells
Interval 0.0 to 3.095
|
0.1735 percentage of cells
Interval 0.0 to 3.095
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD8 HPV-11 Ki67+GrzA+GrzB+Prf+: Week 52
|
0.0501 percentage of cells
Interval 0.0 to 0.8032
|
0.19201 percentage of cells
Interval 0.0 to 11.8539
|
0.64726 percentage of cells
Interval 0.0 to 2.9967
|
0.14403 percentage of cells
Interval 0.0 to 11.8539
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 CD38+: Week 9
|
0.1613 percentage of cells
Interval 0.0 to 0.94
|
0.3743 percentage of cells
Interval 0.0 to 3.307
|
0 percentage of cells
Interval 0.0 to 1.013
|
0.1736 percentage of cells
Interval 0.0 to 3.307
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 CD38+: Week 52
|
0 percentage of cells
Interval 0.0 to 0.808
|
0 percentage of cells
Interval 0.0 to 1.357
|
0.3262 percentage of cells
Interval 0.0 to 0.843
|
0 percentage of cells
Interval 0.0 to 1.357
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-11 CD38+: Week 52
|
0 percentage of cells
Interval 0.0 to 0.496
|
0 percentage of cells
Interval 0.0 to 2.307
|
0.4496 percentage of cells
Interval 0.0 to 2.586
|
0.0273 percentage of cells
Interval 0.0 to 2.586
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 Ki67+: Baseline
|
0 percentage of cells
Interval 0.0 to 1.475
|
0.0127 percentage of cells
Interval 0.0 to 1.196
|
0.0913 percentage of cells
Interval 0.0 to 0.834
|
0.0127 percentage of cells
Interval 0.0 to 1.475
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 Ki67+: Week 6
|
0.0075 percentage of cells
Interval 0.0 to 1.923
|
0 percentage of cells
Interval 0.0 to 1.792
|
0 percentage of cells
Interval 0.0 to 0.913
|
0 percentage of cells
Interval 0.0 to 1.923
|
|
Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs
CD4 HPV-6 Ki67+: Week 9
|
0.284 percentage of cells
Interval 0.0 to 1.025
|
0.0778 percentage of cells
Interval 0.0 to 2.422
|
0.153 percentage of cells
Interval 0.0 to 0.466
|
0.1786 percentage of cells
Interval 0.0 to 2.422
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52Population: MITT population included all participants who had received at least one dose of INO-3107. "Overall number of participants analyzed" are the number of participants available for analyses. "Number analyzed" are the number of participants with data available at specified timepoint.
Pro-inflammatory elements:granulysin (GNLY),C-X-C motif chemokine receptor 6(CXCR6),C-C motif chemokine receptor 5(CCR5),CXCR3, granzyme A(GZMA),interferon regulatory factor1(IRF1),integrin subunit alpha 1(ITGA1),lymphocyte-specific protein tyrosine kinase(LCK),natural killer cell granule protein 7(NKG7),perforin-1(PRF1),eomesodermin(EOMES),CD3 delta subunit of T cell receptor complex(CD3D),CD3 epsilon subunit of T cell receptor complex(CD3E),\&CD8 subunit alpha(CD8A) in papilloma tissues are reported. Reads that mapped to transcript of each gene were counted to measure expression levels for genes from each sample. Raw counts per gene were generated. Counts per million (CPM) mapped reads were calculated \& globally normalized across samples using trimmed mean of M values (TMM).
Outcome measures
| Measure |
INO-3107: Group 1
n=6 Participants
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 Participants
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 Participants
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107 Overall
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
GNLY: at Week 52
|
0.73750 TMM normalized CPM
Interval 0.1798 to 2.9263
|
1.91835 TMM normalized CPM
Interval 0.145 to 9.6759
|
1.73507 TMM normalized CPM
Interval 0.2574 to 3.65
|
0.76142 TMM normalized CPM
Interval 0.145 to 9.6759
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
CXCR6: at Week 52
|
1.88430 TMM normalized CPM
Interval 0.6066 to 3.5441
|
1.60148 TMM normalized CPM
Interval 0.2629 to 6.0563
|
2.07033 TMM normalized CPM
Interval 0.2231 to 3.232
|
1.60148 TMM normalized CPM
Interval 0.2231 to 6.0563
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
CCR5: at Week 52
|
2.90355 TMM normalized CPM
Interval 0.5027 to 6.9744
|
1.56372 TMM normalized CPM
Interval 0.4382 to 13.6821
|
2.97363 TMM normalized CPM
Interval 0.4461 to 7.6166
|
1.85131 TMM normalized CPM
Interval 0.4382 to 13.6821
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
CXCR3: at Week 52
|
1.25062 TMM normalized CPM
Interval 0.2757 to 2.0716
|
1.34513 TMM normalized CPM
Interval 0.2357 to 7.0989
|
2.16235 TMM normalized CPM
Interval 0.4633 to 4.6742
|
1.34513 TMM normalized CPM
Interval 0.2357 to 7.0989
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
ITGA1: at Week 52
|
23.70493 TMM normalized CPM
Interval 6.5519 to 52.428
|
16.72652 TMM normalized CPM
Interval 6.9498 to 109.2069
|
28.30130 TMM normalized CPM
Interval 8.8053 to 72.4943
|
24.28838 TMM normalized CPM
Interval 6.5519 to 109.2069
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
LCK: at Week 52
|
4.94016 TMM normalized CPM
Interval 2.2056 to 10.397
|
4.86932 TMM normalized CPM
Interval 1.8113 to 22.0991
|
7.00865 TMM normalized CPM
Interval 1.4585 to 12.0301
|
4.86932 TMM normalized CPM
Interval 1.4585 to 22.0991
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
GZMA: at Week 52
|
1.20072 TMM normalized CPM
Interval 0.4054 to 2.6318
|
1.38558 TMM normalized CPM
Interval 0.5405 to 6.1197
|
1.24845 TMM normalized CPM
Interval 0.1887 to 2.2678
|
1.38558 TMM normalized CPM
Interval 0.1887 to 6.1197
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
IRF1: at Week 52
|
34.92084 TMM normalized CPM
Interval 22.5842 to 43.4012
|
37.90509 TMM normalized CPM
Interval 20.7243 to 68.1339
|
45.84499 TMM normalized CPM
Interval 27.7316 to 63.7432
|
38.90407 TMM normalized CPM
Interval 20.7243 to 68.1339
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
EOMES: at Week 52
|
0.21977 TMM normalized CPM
Interval 0.0597 to 1.7068
|
0.21910 TMM normalized CPM
Interval 0.0 to 5.7653
|
0.63293 TMM normalized CPM
Interval 0.0 to 1.7133
|
0.22704 TMM normalized CPM
Interval 0.0 to 5.7653
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
CD3D: at Week 52
|
2.54442 TMM normalized CPM
Interval 0.8757 to 5.3288
|
1.23287 TMM normalized CPM
Interval 0.6427 to 16.7749
|
2.58619 TMM normalized CPM
Interval 0.6863 to 8.1566
|
1.64229 TMM normalized CPM
Interval 0.6427 to 16.7749
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
NKG7: at Week 52
|
1.01613 TMM normalized CPM
Interval 0.4703 to 3.1702
|
1.38558 TMM normalized CPM
Interval 0.0907 to 5.4984
|
1.00811 TMM normalized CPM
Interval 0.1373 to 2.7159
|
1.38558 TMM normalized CPM
Interval 0.0907 to 5.4984
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
PRF1: at Week 52
|
1.45396 TMM normalized CPM
Interval 0.78 to 4.6821
|
1.10493 TMM normalized CPM
Interval 0.2375 to 13.0797
|
2.48319 TMM normalized CPM
Interval 0.4118 to 4.848
|
1.22425 TMM normalized CPM
Interval 0.2375 to 13.0797
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
CD3E: at Week 52
|
2.58088 TMM normalized CPM
Interval 1.3947 to 8.7293
|
1.82105 TMM normalized CPM
Interval 0.7596 to 15.7781
|
3.30506 TMM normalized CPM
Interval 0.755 to 8.5663
|
1.82105 TMM normalized CPM
Interval 0.755 to 15.7781
|
|
Pro-inflammatory Elements in Resected Tumor Tissues Assessed by Ribo-nucleic Acid (RNA) Sequencing
CD8A: at Week 52
|
1.90536 TMM normalized CPM
Interval 0.2757 to 2.9587
|
0.87093 TMM normalized CPM
Interval 0.0907 to 13.7614
|
1.67366 TMM normalized CPM
Interval 0.3946 to 5.9887
|
1.29886 TMM normalized CPM
Interval 0.0907 to 13.7614
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6Outcome measures
Outcome data not reported
Adverse Events
INO-3107: Group 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
INO-3107: Group 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
INO-3107: Group 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
INO-3107: Overall
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INO-3107: Group 1
n=6 participants at risk
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 participants at risk
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 participants at risk
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Overall
n=32 participants at risk
Overall number of participants analyzed is the number of participants available for analyses. All participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
Other adverse events
| Measure |
INO-3107: Group 1
n=6 participants at risk
Participants who had ≤ 2 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 2
n=18 participants at risk
Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Group 3
n=8 participants at risk
Participants who had ≥ 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
INO-3107: Overall
n=32 participants at risk
Overall number of participants analyzed is the number of participants available for analyses. All participants who had less ≤ 2 surgeries, 3-5 surgeries and ≥ 6 surgeries, received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
6.2%
2/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
6.2%
2/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Injection site pain
|
33.3%
2/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
33.3%
6/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
25.0%
2/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
31.2%
10/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Injection site swelling
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
11.1%
2/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
6.2%
2/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Localised oedema
|
16.7%
1/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Malaise
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
General disorders
Fatigue
|
33.3%
2/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
11.1%
2/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
15.6%
5/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
6.2%
2/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
25.0%
2/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
4/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Psychiatric disorders
Procedural anxiety
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
5.6%
1/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
0.00%
0/18 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
12.5%
1/8 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
3.1%
1/32 • All-cause mortality: up to Week 52; Serious AEs and non-serious AEs: from first dose of study drug through 30 days following the last dose (i.e., TEAEs) (approximately up to Week 13)
The safety population included all participants who received at least one dose of INO-3107. The data for serious TEAEs is reported in serious adverse events section and for non-serious TEAEs (excluding serious) has been reported in other adverse events sections. MedDRA version used for serious TEAEs: 25.0; and for non-serious TEAEs: 27.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER