Trial Outcomes & Findings for GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study (NCT NCT03769844)
NCT ID: NCT03769844
Last Updated: 2026-05-05
Results Overview
Success in a cohort is defined as improvement in the whole blood ex vivo LPS-induced TNF-alpha production capacity (TNF response) to \>= 200 pg/ml by the morning after the 3rd dose and persisting to the morning after the 7th dose in at least 8 out of 10 treated subjects within a cohort
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
Subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced MODS
Results posted on
2026-05-05
Participant Flow
All patients admitted to the pediatric or cardiac ICU at CPCCRN sites will be evaluated for study eligibility. Patients who meet inclusion criteria will be entered into the data capture system and exclusion criteria will be recorded in that system. If the patient is eligible (no exclusion criteria are present) then the legal guardian(s) will be approached and offered the opportunity for their child to participate in the GRACE study.
After enrollment, subjects undergo measurement of the TNF response, with ONLY those having immunoparalysis (TNF response \<200pg/ml) going on to get study drug. Many subjects who are consented for immune phenotyping do NOT have immunoparalysis, so the number of subjects assigned to an interventional cohort will be fewer than the number consented. Since an adequate immune response was achieved with the 125 mcg/m2/dose strategy, no subjects were enrolled in the 250 mcg/m2/dose arms.
Participant milestones
| Measure |
IV GM-CSF 125 mcg/m2/Dose
Subjects in this arm who demonstrate immunoparalysis will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
SQ GM-CSF 125 mcg/m2/Dose
Subjects in this arm who demonstrate immunoparalysis will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
Baseline characteristics by cohort
| Measure |
IV GM-CSF 125 mcg/m2/Dose
n=10 Participants
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
SQ GM-CSF 125 mcg/m2/Dose
n=9 Participants
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Age, Continuous
|
2.85 years
n=54 Participants
|
5 years
n=60 Participants
|
3.3 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
9 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
|
3 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
16 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Initial TNF response
|
117 pg/ml
n=54 Participants
|
134 pg/ml
n=60 Participants
|
126 pg/ml
n=114 Participants
|
PRIMARY outcome
Timeframe: Subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced MODSSuccess in a cohort is defined as improvement in the whole blood ex vivo LPS-induced TNF-alpha production capacity (TNF response) to \>= 200 pg/ml by the morning after the 3rd dose and persisting to the morning after the 7th dose in at least 8 out of 10 treated subjects within a cohort
Outcome measures
| Measure |
IV GM-CSF 125 mcg/m2/Dose
n=10 Participants
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
SQ GM-CSF 125 mcg/m2/Dose
n=9 Participants
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
|---|---|---|
|
Number of Subjects With Restoration of the TNF-alpha Response
|
10 Participants
|
8 Participants
|
Adverse Events
SQ GM-CSF 125 mcg/m2/Dose
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
IV GM-CSF 125 mcg/m2/Dose
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SQ GM-CSF 125 mcg/m2/Dose
n=9 participants at risk
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
IV GM-CSF 125 mcg/m2/Dose
n=10 participants at risk
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
|---|---|---|
|
Infections and infestations
Wound infection
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Bacteremia
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Intra-abdominal abscess
|
11.1%
1/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
Other adverse events
| Measure |
SQ GM-CSF 125 mcg/m2/Dose
n=9 participants at risk
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
IV GM-CSF 125 mcg/m2/Dose
n=10 participants at risk
Subjects in this arm who demonstrate immunoparalysis (a TNF response \< 200 pg/ml) will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Renal and urinary disorders
BUN increased
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Immune system disorders
Elevated CRP
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Psychiatric disorders
Delirium
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm paralysis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Alkalosis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Number of events 4 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Increased aPTT
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Hepatobiliary disorders
Elevated bilirubin
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Cardiac disorders
Bradycardia
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Renal and urinary disorders
Low BUN
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
General disorders
Fever
|
66.7%
6/9 • Number of events 8 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
60.0%
6/10 • Number of events 7 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Elevated D-dimer
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Head injury
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Hepatobiliary disorders
Hepatic infarction
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Hepatobiliary disorders
Hepatomegaly
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Cardiac disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
30.0%
3/10 • Number of events 3 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
3/9 • Number of events 3 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Cardiac disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Thrombosis - IVC
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
66.7%
6/9 • Number of events 6 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Gastrointestinal disorders
Increased lipase
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Confusion
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Opiate withdrawal
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Decreased oxygen saturation
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Pain
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Pyelonephritis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
30.0%
3/10 • Number of events 3 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Red-man syndrome
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - recurrent
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Septic embolism
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Cardiac disorders
Tachycardia
|
22.2%
2/9 • Number of events 3 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
33.3%
3/9 • Number of events 3 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
30.0%
3/10 • Number of events 3 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Thrombosis - dural sinus
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Cardiac disorders
Tricuspid regurgitation
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Renal and urinary disorders
Bladder distention
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Central line infection
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Delayed wound closure
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Gram positive infection
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Hepatobiliary disorders
Elevated GGT
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Gastrointestinal disorders
Increased nasogastric output
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Metabolism and nutrition disorders
Poor feeding
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Pseudomeningocele
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Intra-abdominal abscess
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Nervous system disorders
Weakness - unilateral
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Elevated procalcitonin
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Cardiac disorders
Elevated BNP
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Infections and infestations
Streptococcus viridans infection
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Increased airway secretions
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Pressure injury
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Skin and subcutaneous tissue disorders
Buttock injury
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/9 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Blood and lymphatic system disorders
Hemorrhage
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
0.00%
0/10 • From first dose of study drug through the following 21 days (or until hospital discharge, whichever occurred first)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place