Trial Outcomes & Findings for Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza (NCT NCT01068912)
NCT ID: NCT01068912
Last Updated: 2015-11-18
Results Overview
Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
530 participants
Primary outcome timeframe
22 weeks
Results posted on
2015-11-18
Participant Flow
Participant milestones
| Measure |
1: Low Dose Favipiravir
Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
|
2: High Dose Favipiravir
Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
|
Placebo
Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
134
|
195
|
201
|
|
Overall Study
COMPLETED
|
123
|
173
|
186
|
|
Overall Study
NOT COMPLETED
|
11
|
22
|
15
|
Reasons for withdrawal
| Measure |
1: Low Dose Favipiravir
Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
|
2: High Dose Favipiravir
Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
|
Placebo
Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
|
Overall Study
aggravation influenza
|
1
|
1
|
1
|
|
Overall Study
other underlying illness
|
0
|
3
|
3
|
Baseline Characteristics
Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
Baseline characteristics by cohort
| Measure |
1: Low Dose Favipiravir
n=132 Participants
Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
|
2: High Dose Favipiravir
n=189 Participants
Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
|
Placebo
n=197 Participants
Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
|
Total
n=518 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
n=5 Participants
|
42.6 years
n=7 Participants
|
42.7 years
n=5 Participants
|
42.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
23 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 participants
n=5 Participants
|
25 participants
n=7 Participants
|
29 participants
n=5 Participants
|
69 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
14 participants
n=5 Participants
|
20 participants
n=7 Participants
|
17 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
72 participants
n=5 Participants
|
103 participants
n=7 Participants
|
115 participants
n=5 Participants
|
290 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race, including Hispanic or Latino
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race, excluding Hispanic or Latino
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
120 participants
n=7 Participants
|
128 participants
n=5 Participants
|
333 participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
24 participants
n=5 Participants
|
36 participants
n=7 Participants
|
36 participants
n=5 Participants
|
96 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Rapid Antigen Test Result
Type A Positive
|
77 participants
n=5 Participants
|
113 participants
n=7 Participants
|
124 participants
n=5 Participants
|
314 participants
n=4 Participants
|
|
Rapid Antigen Test Result
Type B positive
|
30 participants
n=5 Participants
|
45 participants
n=7 Participants
|
43 participants
n=5 Participants
|
118 participants
n=4 Participants
|
|
Rapid Antigen Test Result
Type A and B positive
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Rapid Antigen Test Result
Influenza negative
|
19 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Virus type identification
A (H1N1) pdm
|
39 participants
n=5 Participants
|
32 participants
n=7 Participants
|
39 participants
n=5 Participants
|
110 participants
n=4 Participants
|
|
Virus type identification
A (H3N2)
|
29 participants
n=5 Participants
|
67 participants
n=7 Participants
|
66 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Virus type identification
B
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
20 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
Virus type identification
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Virus type identification
Neither
|
43 participants
n=5 Participants
|
67 participants
n=7 Participants
|
72 participants
n=5 Participants
|
182 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 22 weeksPopulation: The primary analysis population for efficacy analyses was the ITTI Population (N=333), defined as all patients who received at least 1 dose of study drug with any available efficacy data after randomization and who tested positive for influenza A or B by PCR assay or culture tests on Day 1 using determinations.
Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.
Outcome measures
| Measure |
1: Low Dose Favipiravir
n=88 Participants
Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
|
2: High Dose Favipiravir
n=121 Participants
Favipiravir:1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
|
Placebo
n=124 Participants
Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
|
|---|---|---|---|
|
Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza
|
100.4 hours
Interval 82.4 to 119.8
|
86.5 hours
Interval 79.2 to 102.1
|
91.9 hours
Interval 70.3 to 105.4
|
Adverse Events
1: Low Dose Favipiravir
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
2: High Dose Favipiravir
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1: Low Dose Favipiravir
n=132 participants at risk
Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
|
2: High Dose Favipiravir
n=189 participants at risk
Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
|
Placebo
n=197 participants at risk
Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
|
|---|---|---|---|
|
Infections and infestations
Vulval abscess
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Nervous system disorders
hepatic encephalopathy
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Respiratory, thoracic and mediastinal disorders
bronchial obstruction
|
0.00%
0/132
|
0.00%
0/189
|
0.51%
1/197 • Number of events 1
|
Other adverse events
| Measure |
1: Low Dose Favipiravir
n=132 participants at risk
Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
|
2: High Dose Favipiravir
n=189 participants at risk
Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
|
Placebo
n=197 participants at risk
Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
|
|---|---|---|---|
|
Infections and infestations
bronchitis
|
0.00%
0/132
|
2.6%
5/189 • Number of events 5
|
1.0%
2/197 • Number of events 2
|
|
Nervous system disorders
dizziness
|
1.5%
2/132 • Number of events 2
|
2.1%
4/189 • Number of events 4
|
3.0%
6/197 • Number of events 6
|
|
Nervous system disorders
headache
|
2.3%
3/132 • Number of events 3
|
2.1%
4/189 • Number of events 4
|
4.6%
9/197 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.3%
3/132 • Number of events 3
|
1.1%
2/189 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Gastrointestinal disorders
diarrhoea
|
2.3%
3/132 • Number of events 3
|
4.8%
9/189 • Number of events 9
|
5.1%
10/197 • Number of events 10
|
|
Gastrointestinal disorders
nausea
|
1.5%
2/132 • Number of events 2
|
2.1%
4/189 • Number of events 4
|
4.6%
9/197 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
rash
|
2.3%
3/132 • Number of events 3
|
0.00%
0/189
|
0.00%
0/197
|
|
Renal and urinary disorders
proteinuria
|
0.76%
1/132 • Number of events 1
|
2.1%
4/189 • Number of events 4
|
0.51%
1/197 • Number of events 1
|
|
Investigations
blood fibrinogen increased
|
3.0%
4/132 • Number of events 4
|
1.6%
3/189 • Number of events 3
|
3.0%
6/197 • Number of events 6
|
|
Investigations
blood uric acid increased
|
2.3%
3/132 • Number of events 3
|
3.7%
7/189 • Number of events 7
|
2.5%
5/197 • Number of events 5
|
|
Infections and infestations
urinary tract infection
|
1.5%
2/132 • Number of events 2
|
0.00%
0/189
|
2.0%
4/197 • Number of events 4
|
|
Gastrointestinal disorders
vomiting
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
2.5%
5/197 • Number of events 5
|
|
Investigations
alanine aminotransferase increase
|
0.00%
0/132
|
1.6%
3/189 • Number of events 3
|
3.0%
6/197 • Number of events 6
|
|
Investigations
blood triglycerides increased
|
1.5%
2/132 • Number of events 2
|
1.1%
2/189 • Number of events 2
|
2.0%
4/197 • Number of events 4
|
|
Investigations
INR increased
|
0.00%
0/132
|
0.00%
0/189
|
2.5%
5/197 • Number of events 5
|
|
Infections and infestations
ear infection
|
1.5%
2/132 • Number of events 2
|
0.00%
0/189
|
0.00%
0/197
|
|
Nervous system disorders
dysgeusia
|
1.5%
2/132 • Number of events 2
|
0.00%
0/189
|
0.00%
0/197
|
|
Cardiac disorders
palpitations
|
0.00%
0/132
|
1.6%
3/189 • Number of events 3
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
1.5%
2/132 • Number of events 2
|
0.00%
0/189
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
respiratory tract congestion
|
1.5%
2/132 • Number of events 2
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Skin and subcutaneous tissue disorders
urticaria
|
1.5%
2/132 • Number of events 2
|
0.00%
0/189
|
0.00%
0/197
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/132
|
0.00%
0/189
|
1.5%
3/197 • Number of events 3
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/132
|
0.00%
0/189
|
1.5%
3/197 • Number of events 3
|
|
Investigations
APTT prolonged
|
0.00%
0/132
|
0.00%
0/189
|
1.5%
3/197 • Number of events 3
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/132
|
1.6%
3/189 • Number of events 3
|
1.5%
3/197 • Number of events 3
|
|
Investigations
Blood creatine phosphokinase increased
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
1.5%
3/197 • Number of events 3
|
|
Investigations
blood creatinine increased
|
1.5%
2/132 • Number of events 2
|
1.1%
2/189 • Number of events 2
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/132
|
1.6%
3/189 • Number of events 3
|
1.5%
3/197 • Number of events 3
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/132
|
0.00%
0/189
|
1.5%
3/197 • Number of events 3
|
|
Investigations
WBC decreased
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Investigations
platelet count decreased
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Investigations
neutrophil count increased
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
0.00%
0/197
|
|
Investigations
neutrophil count decreased
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Reproductive system and breast disorders
pelvic pain
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Reproductive system and breast disorders
breast tenderness
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Renal and urinary disorders
ketonuria
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/132
|
1.1%
2/189 • Number of events 2
|
0.00%
0/197
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
0.00%
0/132
|
0.53%
1/189 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/132
|
1.1%
2/189 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Infections and infestations
rhinitis
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Infections and infestations
otitis media
|
0.00%
0/132
|
0.53%
1/189 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Infections and infestations
sinusitis
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
0.51%
1/197 • Number of events 1
|
|
Infections and infestations
tonsillits
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Infections and infestations
viral upper respiratory tract infection
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Infections and infestations
vulval abscess
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Infections and infestations
pharyngitis bacterial
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Infections and infestations
sinusitis bacterial
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Blood and lymphatic system disorders
leukopenia
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
0.00%
0/197
|
|
Nervous system disorders
hepatic encephalopathy
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Nervous system disorders
parasthesia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Nervous system disorders
somnolence
|
0.00%
0/132
|
0.00%
0/189
|
1.0%
2/197 • Number of events 2
|
|
Ear and labyrinth disorders
ear pain
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
0.00%
0/197
|
|
Ear and labyrinth disorders
tympanic membrane disorder
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Vascular disorders
hypertension
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysis
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pharyngeal erythema
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
abdominal distension
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Gastrointestinal disorders
aphthous stomatitis
|
0.76%
1/132
|
0.53%
1/189
|
0.51%
1/197
|
|
Gastrointestinal disorders
constipation
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
dry mouth
|
0.76%
1/132 • Number of events 1
|
1.1%
2/189 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/132
|
0.53%
1/189 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Gastrointestinal disorders
dysphagia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Gastrointestinal disorders
flatulence
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Gastrointestinal disorders
gastritis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
1.0%
2/197 • Number of events 2
|
|
Gastrointestinal disorders
sensitivity of teeth
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.76%
1/132 • Number of events 1
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Skin and subcutaneous tissue disorders
rash erythematous
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Skin and subcutaneous tissue disorders
hypoaesthesia facial
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Renal and urinary disorders
leukocyturia
|
0.00%
0/132
|
0.00%
0/189
|
1.0%
2/197 • Number of events 2
|
|
General disorders
asthenia
|
0.00%
0/132
|
1.1%
2/189 • Number of events 2
|
0.51%
1/197 • Number of events 1
|
|
General disorders
pyrexia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/189
|
0.00%
0/197
|
|
Investigations
C-reactive protein increased
|
1.5%
2/132 • Number of events 2
|
1.1%
2/189 • Number of events 2
|
1.5%
3/197 • Number of events 3
|
|
Investigations
gamma-glutamyl transferase increased
|
0.00%
0/132
|
1.6%
3/189 • Number of events 3
|
1.5%
3/197 • Number of events 3
|
|
Investigations
lymphocyte count decreased
|
1.5%
2/132 • Number of events 2
|
0.53%
1/189 • Number of events 1
|
0.00%
0/197
|
|
Investigations
blood phosphorus increased
|
0.00%
0/132
|
0.00%
0/189
|
1.0%
2/197 • Number of events 2
|
|
Investigations
bilibrubin urine
|
0.00%
0/132
|
1.1%
2/189 • Number of events 2
|
0.00%
0/197
|
|
Metabolism and nutrition disorders
hypertriglyceridaemia
|
0.00%
0/132
|
0.00%
0/189
|
1.0%
2/197 • Number of events 2
|
|
Investigations
WBC increased
|
0.00%
0/132
|
1.1%
2/189 • Number of events 2
|
0.00%
0/197
|
Additional Information
Dr. Carol Epstein, Chief Medical Officer
MediVector, Inc., managing member MDVI, LLC
Phone: 617-439-4500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60