Trial Outcomes & Findings for A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection (NCT NCT04343989)
NCT ID: NCT04343989
Last Updated: 2022-06-14
Results Overview
Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
28 days
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
Clazakizumab 25 mg
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
78
|
26
|
74
|
|
Overall Study
COMPLETED
|
78
|
26
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
65.7 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
62.3 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
123 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=99 Participants
|
26 participants
n=107 Participants
|
74 participants
n=206 Participants
|
178 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 28 daysVentilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days.
Outcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Ventilator Free Survival
|
58 Participants
|
19 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: 60 daysOutcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab
|
46 Serious Adverse Events
|
6 Serious Adverse Events
|
51 Serious Adverse Events
|
SECONDARY outcome
Timeframe: 28 daysOverall Patient Survival is defined as the total number of patients per group who were alive at 28 days
Outcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Overall Patient Survival
|
60 Participants
|
20 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 60 daysOverall patient survival is defined as total number of patients per group who were alive at 60 days.
Outcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Overall Patient Survival
|
56 Participants
|
20 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 28 daysChange in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 \>/= 150 or SpO2/FiO2 \>/= 200, 8 = mechanical ventilation pO2/FiO2 \< 150 (SpO2/FiO2 \< 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 \< 150 and vasopressors, dialysis, or ECMO, and 10 = Dead
Outcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Number of Participants With Change in Clinical Status
|
50 Participants
|
15 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 60 daysChange in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 \>/= 150 or SpO2/FiO2 \>/= 200, 8 = mechanical ventilation pO2/FiO2 \< 150 (SpO2/FiO2 \< 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 \< 150 and vasopressors, dialysis, or ECMO, and 10 = Dead
Outcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Number of Participants With a Change in Clinical Status
|
54 Participants
|
17 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 60 daysOutcome measures
| Measure |
Clazakizumab 25 mg
n=78 Participants
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 Participants
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 Participants
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Number of Clazakizumab-expected Adverse Events
|
7 Adverse Events
|
3 Adverse Events
|
12 Adverse Events
|
Adverse Events
Clazakizumab 25 mg
Serious events: 24 serious events
Other events: 76 other events
Deaths: 22 deaths
Clazakizumab 12.5 mg
Serious events: 6 serious events
Other events: 24 other events
Deaths: 6 deaths
Placebo
Serious events: 33 serious events
Other events: 72 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Clazakizumab 25 mg
n=78 participants at risk
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 participants at risk
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 participants at risk
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
General disorders
hypotension
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Infections and infestations
infections
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
intracranial hemorrhage
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
lower respiratory infection
|
6.4%
5/78 • 60 days
|
0.00%
0/26 • 60 days
|
6.8%
5/74 • 60 days
|
|
Blood and lymphatic system disorders
lymphocyte count increased
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
General disorders
multi-organ failure
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Nervous system disorders
muscle weakness
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Blood and lymphatic system disorders
platelet count decreased
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
7.7%
6/78 • 60 days
|
0.00%
0/26 • 60 days
|
9.5%
7/74 • 60 days
|
|
Infections and infestations
sepsis
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Infections and infestations
urinary tract infection
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Vascular disorders
visceral arterial ischemia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Metabolism and nutrition disorders
acidosis
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Renal and urinary disorders
acute kidney injury
|
3.8%
3/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
adult respiratory distress syndrome
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Hepatobiliary disorders
alanine aminotransferase increased
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Hepatobiliary disorders
aspartate aminotransferase increased
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Infections and infestations
bacteremia
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
bronchopleural fistula
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Cardiac disorders
cardiac arrest
|
17.9%
14/78 • 60 days
|
23.1%
6/26 • 60 days
|
25.7%
19/74 • 60 days
|
|
Gastrointestinal disorders
gastric hemorrhage
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Cardiac disorders
heart failure
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
Other adverse events
| Measure |
Clazakizumab 25 mg
n=78 participants at risk
Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
|
Clazakizumab 12.5 mg
n=26 participants at risk
Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
|
Placebo
n=74 participants at risk
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal distension
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Metabolism and nutrition disorders
acidosis
|
5.1%
4/78 • 60 days
|
7.7%
2/26 • 60 days
|
6.8%
5/74 • 60 days
|
|
Hepatobiliary disorders
alanine aminotransferase increased
|
23.1%
18/78 • 60 days
|
15.4%
4/26 • 60 days
|
28.4%
21/74 • 60 days
|
|
Hepatobiliary disorders
alkaline phosphatase increased
|
5.1%
4/78 • 60 days
|
0.00%
0/26 • 60 days
|
8.1%
6/74 • 60 days
|
|
General disorders
alopecia
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Blood and lymphatic system disorders
Anemia
|
21.8%
17/78 • 60 days
|
42.3%
11/26 • 60 days
|
43.2%
32/74 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
Aphonia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Hepatobiliary disorders
aspartate minotransferase increased
|
12.8%
10/78 • 60 days
|
0.00%
0/26 • 60 days
|
14.9%
11/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
16.2%
12/74 • 60 days
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Infections and infestations
Bacteremia
|
5.1%
4/78 • 60 days
|
3.8%
1/26 • 60 days
|
8.1%
6/74 • 60 days
|
|
Metabolism and nutrition disorders
blood bicarbonate decreased
|
3.8%
3/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Hepatobiliary disorders
blood bilirubin increased
|
5.1%
4/78 • 60 days
|
0.00%
0/26 • 60 days
|
5.4%
4/74 • 60 days
|
|
Nervous system disorders
Blurred vision
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
bronchopleural fistula
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
bronchopulmonary hemorrahge
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Cardiac disorders
Cardiac Arrest
|
1.3%
1/78 • 60 days
|
7.7%
2/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Cardiac disorders
cardiac troponin increased
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Cardiac disorders
chest pain-cardiac
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
General disorders
Chills
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
cognitive disturbance
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
Confusion
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Renal and urinary disorders
creatinine increased
|
17.9%
14/78 • 60 days
|
34.6%
9/26 • 60 days
|
33.8%
25/74 • 60 days
|
|
Renal and urinary disorders
cystitis
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Infections and infestations
cytomegalovirus infection
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Metabolism and nutrition disorders
dehydration
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Nervous system disorders
delirium
|
2.6%
2/78 • 60 days
|
3.8%
1/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Nervous system disorders
depressed level of consciousness
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Blood and lymphatic system disorders
disseminated intravascular coagulation
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Nervous system disorders
dysphagia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
encephalopathy
|
1.3%
1/78 • 60 days
|
3.8%
1/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Blood and lymphatic system disorders
eosinophilia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
General disorders
epistaxis
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
General disorders
fall
|
3.8%
3/78 • 60 days
|
3.8%
1/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
General disorders
fever
|
30.8%
24/78 • 60 days
|
61.5%
16/26 • 60 days
|
79.7%
59/74 • 60 days
|
|
Blood and lymphatic system disorders
fibrinogen decreased
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Infections and infestations
fungemia
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Gastrointestinal disorders
gastric hemorrhage
|
0.00%
0/78 • 60 days
|
3.8%
1/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Ear and labyrinth disorders
hearing impaired
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
General disorders
hematoma
|
3.8%
3/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Renal and urinary disorders
hematuria
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Hepatobiliary disorders
hepatic necrosis
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Hepatobiliary disorders
hepatobiliary disoders, other
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Infections and infestations
herpes simplex reactivation
|
0.00%
0/78 • 60 days
|
3.8%
1/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Endocrine disorders
hyperglycemia
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Metabolism and nutrition disorders
hyperkalemia
|
10.3%
8/78 • 60 days
|
7.7%
2/26 • 60 days
|
16.2%
12/74 • 60 days
|
|
Metabolism and nutrition disorders
hyperlipidemia
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
5.4%
4/74 • 60 days
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
6.4%
5/78 • 60 days
|
0.00%
0/26 • 60 days
|
5.4%
4/74 • 60 days
|
|
Metabolism and nutrition disorders
hypernatremia
|
6.4%
5/78 • 60 days
|
3.8%
1/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
General disorders
hypertension
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
6.4%
5/78 • 60 days
|
0.00%
0/26 • 60 days
|
8.1%
6/74 • 60 days
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
6.8%
5/74 • 60 days
|
|
Metabolism and nutrition disorders
hyponatremia
|
6.4%
5/78 • 60 days
|
0.00%
0/26 • 60 days
|
8.1%
6/74 • 60 days
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
5.1%
4/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
General disorders
hypotension
|
30.8%
24/78 • 60 days
|
61.5%
16/26 • 60 days
|
56.8%
42/74 • 60 days
|
|
General disorders
hypothermia
|
3.8%
3/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
17.9%
14/78 • 60 days
|
30.8%
8/26 • 60 days
|
39.2%
29/74 • 60 days
|
|
Gastrointestinal disorders
ileus
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Blood and lymphatic system disorders
inr increased
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Nervous system disorders
intracranial hemorrhage
|
1.3%
1/78 • 60 days
|
3.8%
1/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Nervous system disorders
lethargy
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Gastrointestinal disorders
lower gastrointestinal hemorrahge
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
lower respiratory infection
|
2.6%
2/78 • 60 days
|
7.7%
2/26 • 60 days
|
12.2%
9/74 • 60 days
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
12.8%
10/78 • 60 days
|
0.00%
0/26 • 60 days
|
10.8%
8/74 • 60 days
|
|
Skin and subcutaneous tissue disorders
maculopapular rash
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Metabolism and nutrition disorders
metabolism and nutrition disorders
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
muscle weakness
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
General disorders
nasal congestion
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Gastrointestinal disorders
oral hemorrhage
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
10.8%
8/74 • 60 days
|
|
Nervous system disorders
paresthesia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Cardiac disorders
pericardial effusion
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Vascular disorders
peripheral ischemia
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Nervous system disorders
peripheral motor neuropathy
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
15.4%
12/78 • 60 days
|
3.8%
1/26 • 60 days
|
6.8%
5/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
4.1%
3/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
6.4%
5/78 • 60 days
|
0.00%
0/26 • 60 days
|
20.3%
15/74 • 60 days
|
|
Nervous system disorders
presyncope
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Renal and urinary disorders
proteinuria
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Renal and urinary disorders
renal calculi
|
0.00%
0/78 • 60 days
|
3.8%
1/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
General disorders
retroperitoneal hemhorrahge
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Cardiac disorders
right ventricular dysfunction
|
0.00%
0/78 • 60 days
|
3.8%
1/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
seizure
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Infections and infestations
sepsis
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Cardiac disorders
sinus bradycardia
|
2.6%
2/78 • 60 days
|
3.8%
1/26 • 60 days
|
2.7%
2/74 • 60 days
|
|
Cardiac disorders
sinus tachycardia
|
5.1%
4/78 • 60 days
|
3.8%
1/26 • 60 days
|
13.5%
10/74 • 60 days
|
|
Infections and infestations
skin & subcutaneous tissue disorders
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Infections and infestations
skin infection
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Skin and subcutaneous tissue disorders
skin ulceration
|
2.6%
2/78 • 60 days
|
3.8%
1/26 • 60 days
|
5.4%
4/74 • 60 days
|
|
Infections and infestations
soft tissue infection
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Skin and subcutaneous tissue disorders
soft tissue necrosis
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Nervous system disorders
somnolence
|
1.3%
1/78 • 60 days
|
3.8%
1/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Gastrointestinal disorders
sore throat
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Nervous system disorders
stroke
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
6.8%
5/74 • 60 days
|
|
Skin and subcutaneous tissue disorders
subcutaneous emphysema
|
1.3%
1/78 • 60 days
|
11.5%
3/26 • 60 days
|
5.4%
4/74 • 60 days
|
|
Cardiac disorders
supraventricular tachycardia
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Cardiac disorders
tachycardia
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Cardiac disorders
tachypnic
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Blood and lymphatic system disorders
thromboembolic event
|
3.8%
3/78 • 60 days
|
11.5%
3/26 • 60 days
|
8.1%
6/74 • 60 days
|
|
Gastrointestinal disorders
thrush
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
tracheal hemorrhage
|
1.3%
1/78 • 60 days
|
3.8%
1/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Metabolism and nutrition disorders
triglycerides increased
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrahge
|
5.1%
4/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
10.3%
8/78 • 60 days
|
42.3%
11/26 • 60 days
|
16.2%
12/74 • 60 days
|
|
Renal and urinary disorders
urinary frequency
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Renal and urinary disorders
urinary retention
|
2.6%
2/78 • 60 days
|
7.7%
2/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Infections and infestations
urinary tract infection
|
2.6%
2/78 • 60 days
|
0.00%
0/26 • 60 days
|
13.5%
10/74 • 60 days
|
|
Cardiac disorders
ventricular tachycardia
|
3.8%
3/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
|
Gastrointestinal disorders
vomiting
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
Metabolism and nutrition disorders
weight loss
|
0.00%
0/78 • 60 days
|
0.00%
0/26 • 60 days
|
1.4%
1/74 • 60 days
|
|
General disorders
multi-organ failure
|
1.3%
1/78 • 60 days
|
0.00%
0/26 • 60 days
|
0.00%
0/74 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place