Trial Outcomes & Findings for PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease (NCT NCT01155362)
NCT ID: NCT01155362
Last Updated: 2026-07-07
Results Overview
Clinical response was defined as a reduction from baseline of at least 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) score at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Week 4 (Day 29) and Week 6 (Day 43)
Results posted on
2026-07-07
Participant Flow
Subjects with moderate-to-severe Crohn's disease were enrolled into sequential study cohorts evaluating intravenous PDA001. The study included open-label dose-escalation cohorts and a randomized, double-blind, placebo-controlled cohort.
Fifty subjects were randomized and received study treatment during the induction phase and were included in the safety population. Efficacy analyses were conducted using the modified intent-to-treat (mITT) population, which included subjects who received investigational product and had at least one efficacy assessment at the Week 4 visit. Two subjects did not meet the mITT definition and were excluded from efficacy analyses.
Participant milestones
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
|---|---|---|---|---|
|
Induction Phase
STARTED
|
15
|
15
|
16
|
4
|
|
Induction Phase
COMPLETED
|
15
|
14
|
16
|
4
|
|
Induction Phase
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Extension and Follow-up Phase
STARTED
|
15
|
14
|
16
|
4
|
|
Extension and Follow-up Phase
COMPLETED
|
7
|
7
|
9
|
3
|
|
Extension and Follow-up Phase
NOT COMPLETED
|
8
|
7
|
7
|
1
|
Reasons for withdrawal
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
|---|---|---|---|---|
|
Induction Phase
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Extension and Follow-up Phase
Lack of Efficacy
|
0
|
1
|
1
|
0
|
|
Extension and Follow-up Phase
Withdrawal by Subject
|
4
|
5
|
6
|
1
|
|
Extension and Follow-up Phase
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Extension and Follow-up Phase
Other
|
3
|
1
|
0
|
0
|
Baseline Characteristics
PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
Baseline characteristics by cohort
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 Participants
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 Participants
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
n=16 Participants
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
n=4 Participants
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 13.95 • n=20 Participants
|
36.2 years
STANDARD_DEVIATION 11.60 • n=20 Participants
|
36.5 years
STANDARD_DEVIATION 7.27 • n=40 Participants
|
32.3 years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 10.90 • n=9 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
27 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
48 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
48 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Crohn's Disease Activity Index (CDAI)
|
303.5 scores on a scale
STANDARD_DEVIATION 66.83 • n=20 Participants
|
323.0 scores on a scale
STANDARD_DEVIATION 61.46 • n=20 Participants
|
329.9 scores on a scale
STANDARD_DEVIATION 116.11 • n=40 Participants
|
299.0 scores on a scale
STANDARD_DEVIATION 61.75 • n=5 Participants
|
317.40 scores on a scale
STANDARD_DEVIATION 82.84 • n=9 Participants
|
PRIMARY outcome
Timeframe: Week 4 (Day 29) and Week 6 (Day 43)Population: Modified intent-to-treat (mITT) population. The mITT population included randomized subjects who received investigational product and had at least one efficacy assessment at the Week 4 visit. Participants included in this analysis had Week 4 and Week 6 CDAI assessments available.
Clinical response was defined as a reduction from baseline of at least 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) score at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.
Outcome measures
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 Participants
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=13 Participants
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
n=15 Participants
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
n=4 Participants
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
|---|---|---|---|---|
|
Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
|
5 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 4 (Day 29) and Week 6 (Day 43)Population: Modified intent-to-treat (mITT) population. The mITT population included randomized subjects who received investigational product and had at least one efficacy assessment at the Week 4 visit. Participants included in this analysis had Week 4 and Week 6 CDAI assessments available.
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of 150 or less at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.
Outcome measures
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 Participants
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=13 Participants
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
n=15 Participants
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
n=4 Participants
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
|---|---|---|---|---|
|
Percentage of Subjects With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Vehicle Control
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 participants at risk
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 participants at risk
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
n=16 participants at risk
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
n=4 participants at risk
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/16 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
25.0%
1/4 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Gastrointestinal disorders
Crohn's disease
|
40.0%
6/15 • Number of events 6 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
40.0%
6/15 • Number of events 6 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
18.8%
3/16 • Number of events 6 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.7%
1/15 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/16 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/16 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Gastrointestinal disorders
Perirectal abscess
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.2%
1/16 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.2%
1/16 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
6.7%
1/15 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.2%
1/16 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
Other adverse events
| Measure |
200 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 participants at risk
PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
800 × 10^6 Cells of Human Placenta-Derived Cells PDA001
n=15 participants at risk
PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.
|
Vehicle Control
n=16 participants at risk
Matching placebo administered intravenously on Study Day 0 and Study Day 7.
|
1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001
n=4 participants at risk
PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.2%
1/16 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
50.0%
2/4 • Number of events 2 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Gastrointestinal disorders
Crohns disease
|
53.3%
8/15 • Number of events 8 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
46.7%
7/15 • Number of events 7 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
25.0%
4/16 • Number of events 4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
25.0%
1/4 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
4/15 • Number of events 4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
26.7%
4/15 • Number of events 4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
18.8%
3/16 • Number of events 3 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
25.0%
1/4 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
General disorders
pyrexia
|
20.0%
3/15 • Number of events 3 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
40.0%
6/15 • Number of events 6 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
25.0%
4/16 • Number of events 4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
13.3%
2/15 • Number of events 2 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
12.5%
2/16 • Number of events 2 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • Number of events 2 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.7%
1/15 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.2%
1/16 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/15 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
13.3%
2/15 • Number of events 2 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
6.2%
1/16 • Number of events 1 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
0.00%
0/4 • 24 months
All adverse events were collected from first administration of study treatment through study completion. Treatment-emergent adverse events (TEAEs) were defined as adverse events occurring or worsening after administration of investigational product. Subjects were followed for up to 24 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place