Trial Outcomes & Findings for Development of Immune Globulin Treatment for Avian Flu (NCT NCT00383071)
NCT ID: NCT00383071
Last Updated: 2018-07-31
Results Overview
The number of subjects experiencing adverse events after receiving H5N1 vaccine
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Day 28, 56, 84
Results posted on
2018-07-31
Participant Flow
Participant milestones
| Measure |
Cohort 2: 120 mcg
120 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
|
Cohort 3: 180 mcg
180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
|
Cohort 4: 180 mcg
120 mcg every 28 days x 2 doses. Subjects randomized to receive vaccination in arm or buttock.
|
Cohort 1: 90 mcg
180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
51
|
25
|
|
Overall Study
COMPLETED
|
25
|
21
|
44
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of Immune Globulin Treatment for Avian Flu
Baseline characteristics by cohort
| Measure |
120 mcg
n=25 Participants
120 mcg IM every 4 weeks for 4 vaccinations
|
180 mcg
n=25 Participants
180 mcg IM every 4 weeks for 4 vaccinations
|
180 mcg Cohort 4
n=51 Participants
180 mcg IM every 4 weeks for 2 vaccinations
|
90 mcg
n=25 Participants
90 mcg IM every 4 weeks for 4 vaccinations
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
LTE18
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
BTWN
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Age, Categorical
GTE65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Hawaiian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 28, 56, 84Population: Primary outcome measure was safety, so below listed numbers are safety population used in AE list.
The number of subjects experiencing adverse events after receiving H5N1 vaccine
Outcome measures
| Measure |
90 mcg
n=25 Participants
90 mcg IM every 4 weeks for 4 vaccinations
|
120 mcg
n=25 Participants
120 mcg IM every 4 weeks for 4 vaccinations
|
180 mcg
n=25 Participants
180 mcg IM every 4 weeks for 4 vaccinations
|
180 mcg Cohort 4
n=51 Participants
120 mcg IM every 4 weeks for 2 vaccinations
|
|---|---|---|---|---|
|
Safety of H5N1 Vaccine as Measured by Adverse Events
|
24 participants
|
24 participants
|
25 participants
|
46 participants
|
Adverse Events
120 mcg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
180 mcg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
180 mcg Cohort 4
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
90 mcg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
120 mcg
n=25 participants at risk
120 mcg every 28 days x 4 doses
|
180 mcg
n=25 participants at risk
180 mcg every 28 days x 4 doses
|
180 mcg Cohort 4
n=51 participants at risk
180 mcg every 28 days x 2 doses
|
90 mcg
n=25 participants at risk
90 mcg every 28 days x 4 doses
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Sickle-cell Disease
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenocarcinoma
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Idiopathic thrombocytopenia
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
120 mcg
n=25 participants at risk
120 mcg every 28 days x 4 doses
|
180 mcg
n=25 participants at risk
180 mcg every 28 days x 4 doses
|
180 mcg Cohort 4
n=51 participants at risk
180 mcg every 28 days x 2 doses
|
90 mcg
n=25 participants at risk
90 mcg every 28 days x 4 doses
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
4.0%
1/25 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Hearing loss
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Otitis, external ear
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Otitis, middle ear
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal gas pains
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
5.9%
3/51 • Number of events 3
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
7.8%
4/51 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Oral aphthous ulcer(s)
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Gastrointestinal disorders
Taste changes
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
General disorders
Acute pain
|
12.0%
3/25 • Number of events 3
|
8.0%
2/25 • Number of events 2
|
5.9%
3/51 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Erythema at injection site
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 2
|
0.00%
0/25
|
9.8%
5/51 • Number of events 5
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Influenza-like disease
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Injection Site Reaction
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Injection site tenderness
|
68.0%
17/25 • Number of events 17
|
80.0%
20/25 • Number of events 20
|
62.7%
32/51 • Number of events 32
|
80.0%
20/25 • Number of events 20
|
|
General disorders
Malaise
|
32.0%
8/25 • Number of events 8
|
24.0%
6/25 • Number of events 6
|
19.6%
10/51 • Number of events 10
|
24.0%
6/25 • Number of events 6
|
|
General disorders
Pain at injection site
|
44.0%
11/25 • Number of events 11
|
48.0%
12/25 • Number of events 12
|
39.2%
20/51 • Number of events 20
|
64.0%
16/25 • Number of events 16
|
|
General disorders
Pruritis associated with injection
|
0.00%
0/25
|
12.0%
3/25 • Number of events 3
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Swelling at injection site
|
0.00%
0/25
|
8.0%
2/25 • Number of events 2
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Abscess
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Infection
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Adhesions, small bowel
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Abnormal serum CPK
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Decreased hemoglobin
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Decreased serum albumin
|
8.0%
2/25 • Number of events 2
|
0.00%
0/25
|
5.9%
3/51 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Elevated ALT(SGPT)
|
8.0%
2/25 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
20.0%
5/25 • Number of events 5
|
|
Investigations
Elevated AST(SGOT)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
|
Investigations
Elevated blood pressure reading without diagnosis of hypertension
|
8.0%
2/25 • Number of events 2
|
0.00%
0/25
|
0.00%
0/51
|
12.0%
3/25 • Number of events 3
|
|
Investigations
Elevated Hematocrit
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Investigations
Elevated Hemoglobin
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Investigations
Elevated serum bilirubin
|
36.0%
9/25 • Number of events 9
|
32.0%
8/25 • Number of events 8
|
37.3%
19/51 • Number of events 19
|
24.0%
6/25 • Number of events 6
|
|
Investigations
Elevated serum creatinine
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Elevated Uric Acid (hyperuricemia)
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
3.9%
2/51 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Heart murmur
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Investigations
Hypercalcemia
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Investigations
Hyperglycemia
|
32.0%
8/25 • Number of events 8
|
8.0%
2/25 • Number of events 2
|
11.8%
6/51 • Number of events 6
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Hyperkalemia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Hypoglycemia
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Hyponatremia
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Hypophosphatemia
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Platelets, decreased
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Pulmonary/Upper Respiratory - other
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Weight loss
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Backache
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Bursitis of hip
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fasciculations
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/25
|
0.00%
0/25
|
3.9%
2/51 • Number of events 2
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal strain
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.0%
8/25 • Number of events 8
|
20.0%
5/25 • Number of events 5
|
15.7%
8/51 • Number of events 8
|
24.0%
6/25 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Spasms
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome (TMJ)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Nervous system disorders
Alterations in neuro-sensory functioning
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Disturbance of skin sensation
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Nervous system disorders
Headache
|
48.0%
12/25 • Number of events 12
|
32.0%
8/25 • Number of events 8
|
25.5%
13/51 • Number of events 13
|
40.0%
10/25 • Number of events 10
|
|
Nervous system disorders
Light headedness
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Vasovagal episode
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Sleep Disturbance
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection (UTI)
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Reproductive system and breast disorders
Atypical squamous cell of undetermined significance (ASCUS)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Benign prostatic hypertrophy
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Acute laryngitis
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute sore throat
|
12.0%
3/25 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
5.9%
3/51 • Number of events 3
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (nonseasonal)
|
12.0%
3/25 • Number of events 3
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (seasonal)
|
8.0%
2/25 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
12.0%
3/25 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
2.0%
1/51 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Nonspecific rhinitis
|
8.0%
2/25 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
2.0%
1/51 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.0%
3/25 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
5.9%
3/51 • Number of events 3
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Streptococcal sore throat
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Idiopathic thrombocytopenia
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
0.00%
0/51
|
0.00%
0/25
|
|
Surgical and medical procedures
Elective surgery
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
0.00%
0/51
|
0.00%
0/25
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 2
|
0.00%
0/25
|
7.8%
4/51 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
|
Vascular disorders
Hypotension
|
0.00%
0/25
|
0.00%
0/25
|
2.0%
1/51 • Number of events 1
|
0.00%
0/25
|
Additional Information
John Beigel, M.D.
SAIC/National Institute of Allergy and Infectious Diseases
Phone: +1 301 451 9881
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place