Trial Outcomes & Findings for Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD. (NCT NCT02264288)
NCT ID: NCT02264288
Last Updated: 2026-06-12
Results Overview
Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Results posted on
2026-06-12
Participant Flow
Subjects were recruited from multiple clinical sites in the United States. A total of 159 subjects were randomized into four treatment groups. The study was terminated early due to a business decision.
Subjects who met eligibility criteria were randomized to one of four treatment groups. A total of 159 subjects were randomized. Analysis populations differ across baseline and efficacy versus safety populations. One subject was excluded from the efficacy evaluable population due to lack of post-baseline efficacy assessments.
Participant milestones
| Measure |
PDA-002 3 × 10^6 Cells
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells.
|
PDA-002 30 × 10^6 Cells
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
44
|
23
|
45
|
|
Overall Study
COMPLETED
|
45
|
42
|
23
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
Baseline characteristics by cohort
| Measure |
PDA-002 3 × 10^6 Cells
n=47 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=43 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells.
|
PDA-002 30 × 10^6 Cells
n=23 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=45 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
36 Participants
n=265 Participants
|
111 Participants
n=568 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
47 Participants
n=568 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
31 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=9 Participants
|
34 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
37 Participants
n=265 Participants
|
127 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=9 Participants
|
37 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
38 Participants
n=265 Participants
|
133 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
45 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=9 Participants
|
31 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
31 Participants
n=265 Participants
|
113 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
PAD Status
Subjects with PAD
|
26 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
31 Participants
n=265 Participants
|
98 Participants
n=568 Participants
|
|
PAD Status
Subjects without PAD
|
21 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
60 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Within 3 months after dosing, with confirmation over the subsequent 4 weeksPopulation: The efficacy evaluable population is a subset of the intent to treat population who were eligible, received any amount of study drug, and had a baseline and at least 1 postbaseline efficacy assessment. A total of 158 subjects met this criteria.
Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=47 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=43 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=23 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=45 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months
|
15 Participants
|
10 Participants
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Within 3 months after dosing, with confirmation over the subsequent 4 weeksPopulation: A total of 158 Efficacy evaluable population. Results are presented by baseline PAD subgroup. Overall numbers analyzed were 47, 43, 23, and 45 for the full efficacy evaluable population among the 3 million, 10 million, 30 million, and the placebo groups respectively. Within the PAD subgroup, numbers analyzed were 26, 27, 14, and 31; within the non-PAD subgroup, numbers analyzed were 21, 16, 9, and 14.
Results are presented by baseline peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks.
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=47 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=43 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=23 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=45 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months by PAD Status
Subjects with PAD
|
10 participants
|
8 participants
|
5 participants
|
7 participants
|
|
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months by PAD Status
Subjects without PAD
|
5 participants
|
2 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Month 3Population: Efficacy evaluable population including subjects with peripheral arterial disease (PAD) who received study treatment and had baseline and at least one post-baseline efficacy assessment. Numbers analyzed were 26, 27, 14, and 31 for the PDA-002 3 × 10\^6, 10 × 10\^6, 30 × 10\^6 dose groups and placebo, respectively.
Responders are defined as subjects who improved by at least 1 numeric Rutherford category from baseline. Results are reported for subjects with peripheral arterial disease (PAD).
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=26 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=27 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=14 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=31 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Percentage of Subjects With Improvement in Rutherford Classification at Month 3 in Subjects With PAD
|
6 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 6Population: Efficacy evaluable population was used for TBI assessments. However, Numbers analyzed at Month 6 were lower than the overall efficacy evaluable population due to missing or unavailable follow-up TBI assessments
TBI was calculated by dividing toe systolic blood pressure by brachial systolic blood pressure using Doppler technique. The average value was used if multiple measurements were available at a study visit.
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=20 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=26 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=10 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=24 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Change From Baseline in Toe-Brachial Index (TBI) at Month 6
|
-0.014 ratio change from baseline
Standard Deviation 0.2244
|
0.015 ratio change from baseline
Standard Deviation 0.2654
|
0.146 ratio change from baseline
Standard Deviation 0.4309
|
0.075 ratio change from baseline
Standard Deviation 0.2315
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 6Population: Efficacy evaluable population was used for TcPO2 assessments. However, Numbers analyzed at Month 6 were lower than the overall efficacy evaluable population due to missing or unavailable follow-up TcPO2 assessments
Transcutaneous oxygen pressure (TcPO2) measurements were used to assess tissue oxygenation. Difference in TcPO2 was calculated as TcPO2 in elevated position minus TcPO2 in supine position.
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=37 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=31 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=13 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=33 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Change From Baseline in Transcutaneous Oxygen Pressure (TcPO2) at Month 6
|
2.7 mmHg
Standard Deviation 25.76
|
0.7 mmHg
Standard Deviation 16.77
|
-1.5 mmHg
Standard Deviation 21.72
|
5.4 mmHg
Standard Deviation 10.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 6Population: Efficacy evaluable population was used for ABI assessments. However, Numbers analyzed at Month 6 were lower than the overall efficacy evaluable population due to missing or unavailable follow-up ABI assessments
ABI was calculated by dividing the systolic blood pressure at the ankle or toe by the systolic blood pressure in the arm using Doppler technique.
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=36 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=37 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=17 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=35 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Change From Baseline in Ankle-Brachial Index (ABI) at Month 6
|
-0.018 ABI ratio change from baseline
Standard Deviation 0.2515
|
0.031 ABI ratio change from baseline
Standard Deviation 0.2527
|
0.039 ABI ratio change from baseline
Standard Deviation 0.2556
|
0.031 ABI ratio change from baseline
Standard Deviation 0.1930
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: Efficacy evaluable population with Month 6 Wagner grade assessments available. Numbers analyzed at Month 6 were lower than the overall efficacy evaluable population due to missing or unavailable follow-up ulcer assessments.
Wagner Grading Scale scores range from Grade 0 (no open lesion) to Grade 5 (extensive gangrene of the entire foot). Lower grades indicate less severe ulceration and better clinical status.
Outcome measures
| Measure |
PDA-002 3 × 10^6 Cells
n=39 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 × 10^6 Cells
n=39 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells
|
PDA-002 30 × 10^6 Cells
n=17 Participants
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=35 Participants
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Percentage of Subjects With Wagner Grade 0 for the Index Ulcer at Month 6
|
21 Participants
|
22 Participants
|
14 Participants
|
19 Participants
|
Adverse Events
PDA-002 3 x 10^6 Cells
Serious events: 23 serious events
Other events: 43 other events
Deaths: 1 deaths
PDA-002 10 x 10^6 Cells
Serious events: 18 serious events
Other events: 42 other events
Deaths: 4 deaths
PDA-002 30 x 10^6 Cells
Serious events: 12 serious events
Other events: 21 other events
Deaths: 3 deaths
Placebo
Serious events: 22 serious events
Other events: 39 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
PDA-002 3 x 10^6 Cells
n=47 participants at risk
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 x 10^6 Cells
n=44 participants at risk
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells.
|
PDA-002 30 x 10^6 Cells
n=23 participants at risk
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=45 participants at risk
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
17.0%
8/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.6%
6/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.0%
3/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
15.6%
7/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Cellulitis
|
8.5%
4/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
11.4%
5/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.9%
4/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Gangrene
|
12.8%
6/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.3%
1/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
11.1%
5/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Infected Skin Ulcer
|
12.8%
6/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.3%
1/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.7%
2/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.4%
2/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Pneumonia
|
4.3%
2/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
6.8%
3/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.2%
1/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.3%
2/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.5%
2/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Nervous system disorders
Diabetic hyperglycemic coma
|
0.00%
0/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.3%
1/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.2%
1/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.3%
1/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.4%
2/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.2%
1/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
Other adverse events
| Measure |
PDA-002 3 x 10^6 Cells
n=47 participants at risk
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 3 × 10\^6 cells.
|
PDA-002 10 x 10^6 Cells
n=44 participants at risk
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 10 × 10\^6 cells.
|
PDA-002 30 x 10^6 Cells
n=23 participants at risk
PDA-002 administered intramuscularly on Study Days 1 and 8 at a dose of 30 × 10\^6 cells.
|
Placebo
n=45 participants at risk
Matching placebo administered intramuscularly on Study Days 1 and 8.
|
|---|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
27.7%
13/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
20.5%
9/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
21.7%
5/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
22.2%
10/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Skin Ulcer
|
34.0%
16/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
18.2%
8/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.7%
2/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
26.7%
12/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Cellulitis
|
19.1%
9/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
18.2%
8/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.0%
3/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
17.8%
8/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Eye disorders
Diabetic Retinopathy
|
8.5%
4/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
11.4%
5/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.0%
3/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.9%
4/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
6.8%
3/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.0%
3/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.9%
4/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
8.5%
4/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
11.4%
5/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.0%
3/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
6.7%
3/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.5%
2/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.7%
2/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
6.7%
3/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Renal and urinary disorders
Urinary tract infection
|
4.3%
2/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.5%
2/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.7%
2/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
6.7%
3/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Gangrene
|
12.8%
6/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
2.3%
1/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
13.3%
6/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
4/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
6.8%
3/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
11.1%
5/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.4%
3/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
9.1%
4/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.3%
1/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.4%
2/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
|
Infections and infestations
Sepsis
|
10.6%
5/47 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
4.5%
2/44 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
0.00%
0/23 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
8.9%
4/45 • Up to 24 Months
A total of 159 subjects were evaluated for safety analysis. All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to study treatment, were collected from informed consent through the last study visit. Treatment-emergent AEs were events that began or worsened after first dose. Serious adverse events reported after the study and considered related to study drug were also included. AEs were collected through systematic assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60