versus: Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine

• Sponsor: TerSera Therapeutics LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04189588
• Collaborator: (none)
• Enrollment: 34
• Locations: 7
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study is designed to compare the number of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.

Condition or Disease	Intervention/Treatment	Phase
Oncology Patients Receiving Chemotherapy	Drug: Cetirizine HCl 10 mg/mL; Drug: Diphenhydramine 50 mg/mL; Drug: anti-CD20 such as Rituximab or Paclitaxel	Phase 2

Detailed Description

This will be a randomized, double-blind exploratory study of IV cetirizine HCl 10 mg/mL versus IV diphenhydramine 50 mg/mL in approximately 34 patients who require premedication for hypersensitivity infusion reactions associated with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. The objectives and purpose of the study will be described to patients presenting at the participating infusion centers. The patients will be randomized to receive either IV cetirizine HCl or IV diphenhydramine.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Randomized Double Blind StudyRandomized Double Blind Study
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Double Blind
• Primary Purpose: Treatment
• Official Title: A Phase 2 Exploratory Study of Intravenous QUZYTTIR™ (Cetirizine Hydrochloride Injection) Versus Intravenous Diphenhydramine in the Prevention of Hypersensitivity Infusion Reactions
• Actual Study Start Date: Mar 25, 2020
• Actual Primary Completion Date: Nov 23, 2020
• Actual Study Completion Date: Dec 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cohort A Cetirizine HCl 10 mg/mL: a single 1 mL injection.	Drug: Cetirizine HCl 10 mg/mL; Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe; Other Names: Quzyttir™ ; Drug: anti-CD20 such as Rituximab or Paclitaxel; Compare the number of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.; Other Names: Rituxan® Taxol Arzerra Ocrevus Gazyva Ruxience Truxima Zevalin
Active Comparator: Cohort B Diphenhydramine 50 mg/mL: a single 1 mL injection.	Drug: Diphenhydramine 50 mg/mL; Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe; Other Names: Benadryl injection® ; Drug: anti-CD20 such as Rituximab or Paclitaxel; Compare the number of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.; Other Names: Rituxan® Taxol Arzerra Ocrevus Gazyva Ruxience Truxima Zevalin

Outcome Measures

Primary Outcome Measures

1. Number of Hypersensitivity Reactions to Treatment With an Anti-CD20 Antibody or Paclitaxel [During and after anti-CD20 agent or paclitaxel infusion, at 1 and 2 hours after the antihistamine injection, at time of discharge, and up through 1 Month post injection of antihistamine (intervention).]

   Compare the number of patients experiencing any infusion reaction events, and the number and percentage of patients experiencing each symptom of infusion reactions (flushing, itching, alterations in heart rate and blood pressure, dyspnea, chest discomfort, acute back or abdominal pain, fever, shaking chills, nausea, vomiting, diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness, or syncope) to treatment with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment after 6 months or in patients with persistent infusion reactions while on maintenance with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. The infusion reactions will be evaluated following the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) definitions of graded infusion reactions.

Secondary Outcome Measures

1. Patient Sedation Scores at 1 Hour and 2 Hours Post-injection of Antihistamine (IV Cetirizine HCl or IV Diphenhydramine) and at Discharge. [1 hour, 2 Hours and at discharge]

   Patient sedation scores at 1 hour and 2 hours post-injection of antihistamine (IV cetirizine HCl or IV diphenhydramine) and at discharge. The patient sedation scores are assessed on a scale of 0-4, with 0=None and 4=Extremely Severe (Asleep, Cannot Self-Rate). The HCP sedation scores are assessed on a scale of 0-4, with 0=None and 4=Extremely severe.

2. Time From Injection to "Readiness for Discharge" [Time to discharge from infusion center]

   Describe the distribution of the amount of time spent in the treatment center prior to discharge (time from injection to "Readiness for Discharge").

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patients who require treatment premedication with an antihistamine for hypersensitivity infusion reactions associated with an anti-CD20, such as Rituxan® (Rituximab) or Paclitaxel, in their first-cycle or re-treatment after 6 months or in patients with persistent infusion reactions while on maintenance or re-treatment.

• 18 years of age or older

Exclusion Criteria:

• Receipt of an investigational drug or device within the past 30 days.

• Patients with likelihood of developing or history of tumor lysis syndrome.(TLS): patients with auto-lyse, Burkitt lymphoma and diffuse large B-cell lymphoma (DLBCL) with bulky disease (single node 7 or more cm or 3 or more nodal sites with size 3 or more cm)

• Patients in whom an antihistamine may be contraindicated (e.g., narrow angle glaucoma, symptomatic prostatic hypertrophy).

• Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg or cetirizine HCl 10 mg.

• Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g., diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine. chlorpheniramine, clemastine, and doxylamine

• Receipt of an H2 antagonist within the past 4 hours, e.g., ranitidine, cimetidine, famotidine, nizatidine.

• Receipt of doxepin within the past 24 hours; doxepin is an antidepressant, but it also has antihistamine properties.

• Receipt of epinephrine (EpiPen® or any other brand) within the past 30 days.

• Has known allergy to hydroxyzine, cetirizine, or levocetirizine, or diphenhydramine.

• Pregnant or breastfeeding.

• Any condition that in the view of the investigator makes the patient unsuitable for enrollment in this study.

• Major medical or psychiatric illness, other than diagnosed cancer at the time of presentation or in the past that in the investigator's judgement they should not be enrolled in this clinical trial.

• Inability to provide informed consent.

• Patients on concomitant P-glycoprotein inhibitors; including antidepressants, antipsychotics (e.g., olanzapine), and benzodiazepines (e.g., alprazolam), as they may cause an increase in sedation.

• Receipt of drugs that cause sedation within the past 24 hours prior to administration of the study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St.Joseph Heritage Care	Napa	California	United States	94558
2	Eisenhower Medical Center	Rancho Mirage	California	United States	92270
3	St. Joseph Heritage Healthcare	Santa Rosa	California	United States	95403
4	Oncology Consultants	Houston	Texas	United States	77030
5	Baylor, Scott, & White Medical Center	Round Rock	Texas	United States	78665
6	Baylor, Scott, & White Medical Center	Temple	Texas	United States	76508
7	Baylor, Scott, & White Medical Center	Waco	Texas	United States	76712

Sponsors and Collaborators

• TerSera Therapeutics LLC

Investigators

• Study Director: Janine North, B.S., TerSera Therapeutics

Study Documents (Full-Text)

• Study Protocol - Nov 24, 2020
• Statistical Analysis Plan - Nov 25, 2020

More Information

Additional Information:

• Results Publication in Journal of Infusion Nursing: Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study

Publications

None provided.

• Responsible Party: TerSera Therapeutics LLC
• ClinicalTrials.gov Identifier: NCT04189588
• Other Study ID Numbers: TER-QZTR-001
• First Posted: Dec 6, 2019
• Last Update Posted: May 17, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Diphenhydramine; Promethazine; Cetirizine; Paclitaxel; Rituximab

Study Results

Participant Flow

Arm/Group Title	Cohort A	Cohort B
Arm/Group Description	Cetirizine HCl 10 mg/mL: a single 1 mL injection. Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.	Diphenhydramine 50 mg/mL: a single 1 mL injection. Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.
Period Title: Overall Study
STARTED	17	17
Completed Treatment	17	17
COMPLETED	17	15
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Cohort A	Cohort B	Total
Arm/Group Description	Cetirizine HCl 10 mg/mL: a single 1 mL injection. Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.	Diphenhydramine 50 mg/mL: a single 1 mL injection. Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.	Total of all reporting groups
Overall Participants	17	17	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.4 (11.83)	66.6 (10.16)	63.5 (11.31)
Sex: Female, Male (Count of Participants)
Female	6 35.3%	6 35.3%	12 35.3%
Male	11 64.7%	11 64.7%	22 64.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 17.6%	3 17.6%	6 17.6%
Not Hispanic or Latino	14 82.4%	14 82.4%	28 82.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	17 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Number of Hypersensitivity Reactions to Treatment With an Anti-CD20 Antibody or Paclitaxel
Description	Compare the number of patients experiencing any infusion reaction events, and the number and percentage of patients experiencing each symptom of infusion reactions (flushing, itching, alterations in heart rate and blood pressure, dyspnea, chest discomfort, acute back or abdominal pain, fever, shaking chills, nausea, vomiting, diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness, or syncope) to treatment with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment after 6 months or in patients with persistent infusion reactions while on maintenance with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. The infusion reactions will be evaluated following the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) definitions of graded infusion reactions.
Time Frame	During and after anti-CD20 agent or paclitaxel infusion, at 1 and 2 hours after the antihistamine injection, at time of discharge, and up through 1 Month post injection of antihistamine (intervention).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B
Arm/Group Description	Cetirizine HCl 10 mg/mL: a single 1 mL injection. Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.	Diphenhydramine 50 mg/mL: a single 1 mL injection. Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.
Measure Participants	17	17
Count of Participants [Participants]	2 11.8%	3 17.6%

2. Secondary Outcome

Title	Patient Sedation Scores at 1 Hour and 2 Hours Post-injection of Antihistamine (IV Cetirizine HCl or IV Diphenhydramine) and at Discharge.
Description	Patient sedation scores at 1 hour and 2 hours post-injection of antihistamine (IV cetirizine HCl or IV diphenhydramine) and at discharge. The patient sedation scores are assessed on a scale of 0-4, with 0=None and 4=Extremely Severe (Asleep, Cannot Self-Rate). The HCP sedation scores are assessed on a scale of 0-4, with 0=None and 4=Extremely severe.
Time Frame	1 hour, 2 Hours and at discharge

Outcome Measure Data

Analysis Population Description

Per Patient Analysis set (patients with a baseline sedation score = 0)

Arm/Group Title	Cohort A	Cohort B
Arm/Group Description	Cetirizine HCl 10 mg/mL: a single 1 mL injection. Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.	Diphenhydramine 50 mg/mL: a single 1 mL injection. Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.
Measure Participants	17	17
1 Hour	0.5 (0.72)	1.3 (1.26)
2 Hour	0.6 (0.61)	0.9 (1.14)
Discharge	0.1 (0.33)	0.4 (0.71)

3. Secondary Outcome

Title	Time From Injection to "Readiness for Discharge"
Description	Describe the distribution of the amount of time spent in the treatment center prior to discharge (time from injection to "Readiness for Discharge").
Time Frame	Time to discharge from infusion center

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A	Cohort B
Arm/Group Description	Cetirizine HCl 10 mg/mL: a single 1 mL injection. Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.	Diphenhydramine 50 mg/mL: a single 1 mL injection. Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.
Measure Participants	17	17
Mean (Standard Deviation) [Hours]	4.3 (1.54)	4.7 (1.26)

Adverse Events

Time Frame	1 month
Arm/Group Title	Cohort A		Cohort B
Arm/Group Description	Cetirizine HCl 10 mg/mL: a single 1 mL injection. Diphenhydramine 50 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.		Diphenhydramine 50 mg/mL: a single 1 mL injection. Cetirizine HCl 10 mg/mL: Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe anti-CD20 such as Rituximab or Paclitaxel: Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.
All Cause Mortality
	Cohort A		Cohort B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		1/17 (5.9%)
Serious Adverse Events
	Cohort A		Cohort B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		1/17 (5.9%)
Blood and lymphatic system disorders
Septic Shock	0/17 (0%)	0	1/17 (5.9%)	1
Other (Not Including Serious) Adverse Events
	Cohort A		Cohort B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.