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Trial Outcomes & Findings for A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction (NCT NCT04614467)

NCT ID: NCT04614467

Last Updated: 2026-05-04

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline to Month 3

Results posted on

2026-05-04

Participant Flow

Participant milestones

Participant milestones
Measure
GCSF-mobilized Autologous CD34+ Cells
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
Placebo: isotonic solution (no CD34+ cells)
Overall Study
STARTED
20
14
Overall Study
COMPLETED
20
14
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
GCSF-mobilized Autologous CD34+ Cells
n=18 Participants
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=14 Participants
Placebo: isotonic solution (no CD34+ cells)
Total
n=32 Participants
Total of all reporting groups
Age, Continuous
59.5 years
STANDARD_DEVIATION 10.75 • n=54 Participants
57.9 years
STANDARD_DEVIATION 8.01 • n=60 Participants
58.8 years
STANDARD_DEVIATION 9.54 • n=114 Participants
Sex: Female, Male
Female
15 Participants
n=54 Participants
13 Participants
n=60 Participants
28 Participants
n=114 Participants
Sex: Female, Male
Male
3 Participants
n=54 Participants
1 Participants
n=60 Participants
4 Participants
n=114 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=54 Participants
1 Participants
n=60 Participants
1 Participants
n=114 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
n=54 Participants
13 Participants
n=60 Participants
28 Participants
n=114 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=54 Participants
0 Participants
n=60 Participants
3 Participants
n=114 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=54 Participants
0 Participants
n=60 Participants
0 Participants
n=114 Participants
Race (NIH/OMB)
Asian
0 Participants
n=54 Participants
0 Participants
n=60 Participants
0 Participants
n=114 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=54 Participants
0 Participants
n=60 Participants
0 Participants
n=114 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=54 Participants
1 Participants
n=60 Participants
1 Participants
n=114 Participants
Race (NIH/OMB)
White
18 Participants
n=54 Participants
13 Participants
n=60 Participants
31 Participants
n=114 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=54 Participants
0 Participants
n=60 Participants
0 Participants
n=114 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=54 Participants
0 Participants
n=60 Participants
0 Participants
n=114 Participants
Region of Enrollment
United States
18 participants
n=54 Participants
14 participants
n=60 Participants
32 participants
n=114 Participants

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Outcome measures

Outcome measures
Measure
GCSF-mobilized Autologous CD34+ Cells
n=13 Participants
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=12 Participants
Placebo: isotonic solution (no CD34+ cells)
Change From Baseline in Number of Angina Attacks Per Week
1.2346 angina attacks per week
Standard Deviation 0.98934
1.4821 angina attacks per week
Standard Deviation 1.33670

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Note that the number of subjects here may be less than in the participant flow module due to missing data.

This measure assesses the change in the Canadian Cardiovascular Society angina class scale. CCS angina class was assessed at baseline and again at 3 months and reported as the mean difference. CCS classes are as follows (negative change indicates an improvement): Class 0: No angina with ordinary activity Class I: Angina only with strenuous, prolonged, or rapid exertion Class II: Angina with slight limitations of ordinary activity (e.g., walking uphill, climbing stairs) Class III: Angina with marked limitations of ordinary activity (e.g., walking one to two blocks, climbing one flight of stairs) Class IV: Angina at rest or with minimal exertion

Outcome measures

Outcome measures
Measure
GCSF-mobilized Autologous CD34+ Cells
n=18 Participants
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=13 Participants
Placebo: isotonic solution (no CD34+ cells)
Change From Baseline in CCS Angina Class
-1.2 units on a scale
Standard Deviation 1.11
-0.8 units on a scale
Standard Deviation 0.73

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Outcome measures

Outcome measures
Measure
GCSF-mobilized Autologous CD34+ Cells
n=12 Participants
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=11 Participants
Placebo: isotonic solution (no CD34+ cells)
Change From Baseline in Total Exercise Time
15.67 minutes
Standard Deviation 84.985
29.82 minutes
Standard Deviation 103.375

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Seattle Angina Questionnaire (SAQ) Scoring is 0 to 100 with higher numbers better

Outcome measures

Outcome measures
Measure
GCSF-mobilized Autologous CD34+ Cells
n=15 Participants
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=11 Participants
Placebo: isotonic solution (no CD34+ cells)
Change From Baseline in Health-related Quality of Life (HRQoL)
15.648 units on a scale
Standard Deviation 22.1382
7.323 units on a scale
Standard Deviation 16.3523

Adverse Events

GCSF-mobilized Autologous CD34+ Cells

Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths

Placebo

Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
GCSF-mobilized Autologous CD34+ Cells
n=20 participants at risk
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=14 participants at risk
Placebo: isotonic solution (no CD34+ cells)
Cardiac disorders
angina pectoris
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
bradycardia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
coronary artery dissection
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
myocardial infarction
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
hypotension
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
deep vein thrombosis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
atrial fibrillation
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
dyspnoea
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
nausea
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
impaired gastric emptying
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
dizziness
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
headache
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
hypoaesthesia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
COVID-19 pneumonia
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.

Other adverse events

Other adverse events
Measure
GCSF-mobilized Autologous CD34+ Cells
n=20 participants at risk
CLBS16: GCSF-mobilized autologous CD34+ cells
Placebo
n=14 participants at risk
Placebo: isotonic solution (no CD34+ cells)
Musculoskeletal and connective tissue disorders
pain in extremity
25.0%
5/20 • Number of events 5 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
myalgia
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
angina pectoris
50.0%
10/20 • Number of events 10 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
35.7%
5/14 • Number of events 5 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
acute myocardial infarction
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
bradycardia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
coronary artery dissection
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
myocardial infarction
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
atrial fibrillation
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
palpitations
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Cardiac disorders
pericarditis
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
neck pain
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
back pain
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
muscle spasms
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
arthralgia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
bone pain
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
intervertebral disc degeneration
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
muscle twitching
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
tendon disorder
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
tendonitis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
groin pain
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
headache
30.0%
6/20 • Number of events 6 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
35.7%
5/14 • Number of events 5 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
dizziness
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
35.7%
5/14 • Number of events 57 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
paresthesia
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
50.0%
7/14 • Number of events 7 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
syncope
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
dysgeusia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
hypoaesthesia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
restless legs syndrome
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Nervous system disorders
migraine
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
nausea
30.0%
6/20 • Number of events 6 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
paraesthesia oral
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
vomiting
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
diarrhoea
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
malabsorption
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
abdominal distension
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
abdominal pain lower
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
abdominal pain upper
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
abnormal faeces
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
constipation
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Gastrointestinal disorders
impaired gastric emptying
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
fatigue
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
28.6%
4/14 • Number of events 4 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
pain
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
catheter site haemorrhage
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
chills
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
feeling abnormal
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
non-cardiac chest pain
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
oedema peripheral
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
peripheral swelling
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
facial discomfort
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
malaise
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
General disorders
medical device pain
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
contusion
25.0%
5/20 • Number of events 5 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
35.7%
5/14 • Number of events 5 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
skin laceration
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
animal bite
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
citrate toxicity
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
craniocerebral injury
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
facial bones fracture
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
fall
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
foot fracture
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
rib fracture
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
vascular access site haemorrhage
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
nasopharyngitis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
vascular access site pain
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Injury, poisoning and procedural complications
skin abrasion
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
hypotension
20.0%
4/20 • Number of events 4 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
haematoma
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
deep vein thrombosis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
hypertension
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Vascular disorders
hot flush
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
urinary tract infection
15.0%
3/20 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
COVID-19
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
21.4%
3/14 • Number of events 3 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
acute sinusitis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
bronchitis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
pharyngitis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
COVID-19 pneumonia
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
candida infection
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
cystitis
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
post-acute COVID-19 syndrome
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
sinusitis bacterial
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Infections and infestations
upper respiratory tract infection
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
dyspnoea
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
bronchiectasis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
bronchitis chronic
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
restrictive pulmonary disease
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
tachypnoea
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
asthma
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
14.3%
2/14 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
painful respiration
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Respiratory, thoracic and mediastinal disorders
status asthmaticus
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Metabolism and nutrition disorders
decreased appetite
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Metabolism and nutrition disorders
fluid retention
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Metabolism and nutrition disorders
hypocalcaemia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Metabolism and nutrition disorders
hypoglycaemia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Metabolism and nutrition disorders
hypokalaemia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Psychiatric disorders
anxiety
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Psychiatric disorders
adjustment disorder with depressed mood
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Psychiatric disorders
insomnia
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Psychiatric disorders
major depression
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Skin and subcutaneous tissue disorders
dermatitis contact
10.0%
2/20 • Number of events 2 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Skin and subcutaneous tissue disorders
pruritis
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Skin and subcutaneous tissue disorders
hyperhidrosis
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Skin and subcutaneous tissue disorders
petechiae
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Reproductive system and breast disorders
breast mass
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Reproductive system and breast disorders
vaginal haemorrhage
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Eye disorders
dry eye
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Investigations
heart rate increased
5.0%
1/20 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
0.00%
0/14 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Blood and lymphatic system disorders
thrombocytopenia
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Ear and labyrinth disorders
cerumen impaction
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Ear and labyrinth disorders
deafness neurosensory
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
Renal and urinary disorders
urinary incontinence
0.00%
0/20 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.

Additional Information

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Phone: 908.842.0100

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  • Principal investigator is a sponsor employee
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