Trial Outcomes & Findings for Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) (NCT NCT04546581)
NCT ID: NCT04546581
Last Updated: 2022-04-04
Results Overview
The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7\. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1\. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories. Primary ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. Minimum value = 1, Maximum value = 7 Higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
593 participants
Primary outcome timeframe
7 days
Results posted on
2022-04-04
Participant Flow
Participant milestones
| Measure |
Intervention Group
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
Overall Study
STARTED
|
301
|
292
|
|
Overall Study
COMPLETED
|
288
|
279
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=301 Participants
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=292 Participants
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
n=5 Participants
|
59.7 years
n=7 Participants
|
59.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
174 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7\. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1\. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories. Primary ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. Minimum value = 1, Maximum value = 7 Higher scores mean a worse outcome
Outcome measures
| Measure |
Intervention Group
n=295 Participants
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=284 Participants
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
Ordinal Outcome Scale - Day 7
Category 7 - Died
|
5 Participants
|
5 Participants
|
|
Ordinal Outcome Scale - Day 7
Category 6 - End organ failure
|
9 Participants
|
13 Participants
|
|
Ordinal Outcome Scale - Day 7
Category 5 - Life threatening end organ dysfunction
|
26 Participants
|
26 Participants
|
|
Ordinal Outcome Scale - Day 7
Category 4 - Serious end organ dysfunction
|
25 Participants
|
30 Participants
|
|
Ordinal Outcome Scale - Day 7
Category 3 - Moderate end organ dysfunction
|
32 Participants
|
28 Participants
|
|
Ordinal Outcome Scale - Day 7
Category 2 - Limiting symptoms due to COVID-19
|
67 Participants
|
61 Participants
|
|
Ordinal Outcome Scale - Day 7
Category 1 - No limiting symptoms due to COVID-19
|
129 Participants
|
116 Participants
|
|
Ordinal Outcome Scale - Day 7
Missing
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Through Day 7Number of participants with death, SAE or Grade 3 or 4 event through Day 7
Outcome measures
| Measure |
Intervention Group
n=295 Participants
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=284 Participants
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
Primary Safety Outcome - Death, SAE or Grade 3 or 4 Events Through Day 7
|
71 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: All of follow-up (through Day 28)N Reaching 3 least favorable categories of ordinal outcome (Categories 5, 6, 7: life-threatening end organ dysfunction, end organ failure, or death)
Outcome measures
| Measure |
Intervention Group
n=295 Participants
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=284 Participants
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
N Reaching 3 Least Favorable Categories
|
45 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: All of follow-up (through Day 28)Population: Those in Category 2 at baseline are excluded from this analysis
N Reaching 2 most favorable categories of ordinal outcome (Categories 1 and 2: not requiring oxygen with or without limiting symptoms due to COVID-19)
Outcome measures
| Measure |
Intervention Group
n=219 Participants
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=206 Participants
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
N Reaching 2 Most Favorable Categories
|
178 Participants
|
160 Participants
|
SECONDARY outcome
Timeframe: All of follow-up (through Day 28)N discharged from hospital or reaching most favorable ordinal category (category 1: not requiring oxygen and no limiting symptoms due to COVID-19)
Outcome measures
| Measure |
Intervention Group
n=295 Participants
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=284 Participants
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
N Discharged or in Most Favorable Category
|
268 Participants
|
252 Participants
|
Adverse Events
Intervention Group
Serious events: 18 serious events
Other events: 79 other events
Deaths: 18 deaths
Control Group
Serious events: 20 serious events
Other events: 53 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Intervention Group
n=301 participants at risk
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=292 participants at risk
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.00%
3/301 • Number of events 3 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 Pneumonia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 2 • 28 days
|
|
Cardiac disorders
Acute left ventricular failure
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Blood and lymphatic system disorders
Acute myeloid leukaemia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Infections and infestations
COVID-19
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
General disorders
Headache
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Blood and lymphatic system disorders
Hypertension
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
General disorders
Pyrexia
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
Other adverse events
| Measure |
Intervention Group
n=301 participants at risk
Participants in this group will receive the investigational product and standard of care (SOC).
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG): Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
Control Group
n=292 participants at risk
Participants in this group will receive a placebo and standard of care (SOC).
Placebo: Participants will receive a single infusion of the placebo (saline).
Remdesivir: Remdesivir will be given to participants in both groups as standard of care (SOC).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
10/301 • Number of events 13 • 28 days
|
1.7%
5/292 • Number of events 6 • 28 days
|
|
General disorders
Pyrexia
|
3.3%
10/301 • Number of events 10 • 28 days
|
1.7%
5/292 • Number of events 6 • 28 days
|
|
General disorders
Chills
|
3.3%
10/301 • Number of events 10 • 28 days
|
0.00%
0/292 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.0%
6/301 • Number of events 7 • 28 days
|
1.7%
5/292 • Number of events 6 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.3%
4/301 • Number of events 4 • 28 days
|
1.0%
3/292 • Number of events 3 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.66%
2/301 • Number of events 2 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
General disorders
Fatigue
|
0.33%
1/301 • Number of events 1 • 28 days
|
1.0%
3/292 • Number of events 3 • 28 days
|
|
Cardiac disorders
Hypotension
|
1.00%
3/301 • Number of events 3 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
General disorders
Ageusia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
Blood and lymphatic system disorders
Anaemia
|
1.00%
3/301 • Number of events 3 • 28 days
|
0.00%
0/292 • 28 days
|
|
General disorders
Anosmia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.00%
3/301 • Number of events 3 • 28 days
|
0.00%
0/292 • 28 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Anxiety
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 pneumonia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
General disorders
Decreased appetite
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Cardiac disorders
Hypertension
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/301 • 28 days
|
0.68%
2/292 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Renal and urinary disorders
Anuria
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
General disorders
Asthenia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Endocrine disorders
Blood glucose increased
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dependence on oxygen therapy
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea, exertional
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Blood and lymphatic system disorders
Haemoptysis
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Blood and lymphatic system disorders
Haemorrhage
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
General disorders
Headache
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Cardiac disorders
Left ventricular failure
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
General disorders
Lethargy
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
General disorders
Malaise
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Oliguria
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Ear and labyrinth disorders
Oropharyngeal pain
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Infections and infestations
Septic shock
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/301 • 28 days
|
0.34%
1/292 • Number of events 1 • 28 days
|
|
Eye disorders
Vision blurred
|
0.33%
1/301 • Number of events 1 • 28 days
|
0.00%
0/292 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place