Trial Outcomes & Findings for A Study of IL-7 to Restore Absolute Lymphocyte Counts in Sepsis Patients (NCT NCT02640807)
NCT ID: NCT02640807
Last Updated: 2020-07-09
Results Overview
Number of patients showing an increase of Absolute Lymphocyte Count \>50% from baseline at Day 42. Kinetic of immune restoration through weekly measures of Absolute Lymphocyte Counts
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Day 0 to 42
Results posted on
2020-07-09
Participant Flow
Participant milestones
| Measure |
CYT107 High Frequency
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
10
|
|
Overall Study
COMPLETED
|
9
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CYT107 High Frequency
n=9 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
n=8 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
n=10 Participants
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=9 Participants
|
68 years
n=8 Participants
|
56 years
n=10 Participants
|
62 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=10 Participants
|
21 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=9 Participants
|
3 participants
n=8 Participants
|
4 participants
n=10 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
France
|
5 participants
n=9 Participants
|
5 participants
n=8 Participants
|
6 participants
n=10 Participants
|
16 participants
n=27 Participants
|
|
SOFA Score
|
6 units on a scale
n=9 Participants
|
5 units on a scale
n=8 Participants
|
8 units on a scale
n=10 Participants
|
6 units on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 42Number of patients showing an increase of Absolute Lymphocyte Count \>50% from baseline at Day 42. Kinetic of immune restoration through weekly measures of Absolute Lymphocyte Counts
Outcome measures
| Measure |
CYT107 High Frequency
n=9 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
n=8 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
n=10 Participants
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
|---|---|---|---|
|
Immune Reconstitution of Lymphocytopenic Sepsis Patients
|
8 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 42Number of Patients with Absolute Lymphocyte Count \> 1.2 at Day 42
Outcome measures
| Measure |
CYT107 High Frequency
n=7 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
n=6 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
n=7 Participants
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
|---|---|---|---|
|
CYT107 Effect on Absolute Lymphocyte Count
|
6 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 60number of patients with binding or neutralizing antibodies against CYT107 at Day 60
Outcome measures
| Measure |
CYT107 High Frequency
n=9 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
n=8 Participants
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
n=10 Participants
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
|---|---|---|---|
|
CYT107 Immunogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
CYT107 High Frequency
Serious events: 7 serious events
Other events: 9 other events
Deaths: 3 deaths
CYT107 Low Frequency
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Control
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CYT107 High Frequency
n=9 participants at risk
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
n=8 participants at risk
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
n=10 participants at risk
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung Abscess
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic event
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Eye disorders
Papilledema
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Cardiac disorders
Tamponade
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Mediastinitis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Relapse of endocarditis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Ischemic Colitis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Oesophago-bronchial fistula
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Nervous system disorders
Ischemic stroke
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Bile leak
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Recurrent septic shock
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Intra-abdominal collections
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Evisceration
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Anastomotic leak
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
General disorders
Multi organ failure
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Cardiac disorders
Septic embolism
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Bowel perforation
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Toxic megacolon
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Wound abscess
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Empyema
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Nervous system disorders
Hypoglycemic coma
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
Other adverse events
| Measure |
CYT107 High Frequency
n=9 participants at risk
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
|
CYT107 Low Frequency
n=8 participants at risk
Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks
Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
Control
n=10 participants at risk
Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks
Placebo: IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Leukocytosis
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High BUN
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Thrombocytosis
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High phosphate
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High magnesium
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Blood and lymphatic system disorders
Coagulopathy/low platelets
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Ileal ulcer
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Intra-abdominal abscess
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
General disorders
Fall
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Exp wheezing
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Low BUN
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Abscess
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic event
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
General disorders
Persisting Fever
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Cardiac disorders
Ventricular tachycardia
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Blood and lymphatic system disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Oral herpes
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Urinary infection
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Endocarditis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Cholestatis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Renal and urinary disorders
Renal failure
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Mediastinitis
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
44.4%
4/9 • Number of events 7 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
50.0%
4/8 • Number of events 6 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Nervous system disorders
Confusion
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Weaning failure
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Hemorrhagic gastric ulcer
|
11.1%
1/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Nervous system disorders
Hypercapnic coma
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
ischemic colitis
|
11.1%
1/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Cardiac disorders
Deep Vein Thrombosis
|
22.2%
2/9 • Number of events 4 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High sodium
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Cardiac disorders
Supra ventricular tachycardia
|
22.2%
2/9 • Number of events 3 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Renal and urinary disorders
Acute renal failure
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Ascites
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Yeast infection
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High potassium
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Cutaneous rash
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High alkaline phosphatase
|
33.3%
3/9 • Number of events 3 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Low phosphate
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Ileus
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Pressure ulcer
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Renal and urinary disorders
Hepatic cytolysis
|
33.3%
3/9 • Number of events 4 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Hypoglycemia
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Necrotizing fingers
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Blood and lymphatic system disorders
Ileopsoas hematoma
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Low Calcium
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
DRESS
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
Wound abscess
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumopathy
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Acidosis
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract colonization
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High amylase
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High lipase
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
General disorders
Fatigue
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
General disorders
Chills
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/10 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Metabolic alkalosis
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Low potassium
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Nervous system disorders
Cerebral sequelae of hypoglycemia
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Infections and infestations
Bacteremia
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Blood and lymphatic system disorders
Hemorrhagic shock
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Blood and lymphatic system disorders
Post operative bleeding
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Gastrointestinal disorders
GI discomfort (cramping/bloating)
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Nervous system disorders
Spasticity
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Low Absolute Lymphocyte Count
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Low sodium
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
High phosphorus
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Ventilator associated pneumonia
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Respiratory, thoracic and mediastinal disorders
Empyema
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
|
Investigations
Hyperglycemia
|
0.00%
0/9 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
0.00%
0/8 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
|
Additional Information
Dr Michel Morre, DVM, Chief Scientific Officer
Revimmune
Phone: +33(0)603357060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place