Trial Outcomes & Findings for Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older (NCT NCT02464163)
NCT ID: NCT02464163
Last Updated: 2017-10-26
Results Overview
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
407 participants
Primary outcome timeframe
42 Days
Results posted on
2017-10-26
Participant Flow
Participant milestones
| Measure |
Panblok 30µg in 2% SE
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 7.5µg in 2% SE
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
102
|
101
|
|
Overall Study
COMPLETED
|
99
|
94
|
97
|
96
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older
Baseline characteristics by cohort
| Measure |
Panblok 7.5µg in 2% SE
n=95 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
n=94 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg in 2% SE
n=99 Participants
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
n=94 Participants
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age, Categorical · <65 Years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Age, Customized
Age, Categorical · >=65 Years
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
201 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
233 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 42 DaysPopulation: Modified Per Protocol Population
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
Outcome measures
| Measure |
Panblok 7.5µg in 2% SE
n=95 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
n=94 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg in 2% SE
n=99 Participants
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
n=94 Participants
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
|---|---|---|---|---|
|
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
|
11 Participants
|
9 Participants
|
15 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Reactogenicity Population
Solicited events of local and systemic reactogenicity Days 0-7
Outcome measures
| Measure |
Panblok 7.5µg in 2% SE
n=100 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
n=101 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg in 2% SE
n=101 Participants
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
n=97 Participants
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
|---|---|---|---|---|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7
7 Days After First Vaccination
|
37 Participants
|
33 Participants
|
33 Participants
|
27 Participants
|
|
Reactogenicity Immediately After Each Injection, Extending to Day 7
7 Days After Second Vaccination
|
30 Participants
|
30 Participants
|
26 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 13 monthsPopulation: Safety Population
Outcome measures
| Measure |
Panblok 7.5µg in 2% SE
n=100 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
n=101 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg in 2% SE
n=102 Participants
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
n=97 Participants
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
|---|---|---|---|---|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Angina unstable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Myocardial infarction
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Sinus bradycardia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Chest pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Appendicitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Cellulitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Rib fracture
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Upper limb fracture
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Arthralgia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Fracture malunion
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Musculoskeletal pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Osteoarthritis
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Osteolysis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Cervicobrachial syndrome
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Syncope
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
VIIth nerve paralysis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Suicide attempt
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Peripheral arterial occlusive disease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 42 DaysPopulation: Safety Population
Unsolicited adverse events (UAEs) Days 0-42.
Outcome measures
| Measure |
Panblok 7.5µg in 2% SE
n=100 Participants
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
n=101 Participants
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg in 2% SE
n=102 Participants
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
n=97 Participants
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
|---|---|---|---|---|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Cardiac disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Ear and labyrinth disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Endocrine disorders
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Eye disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Gastrointestinal disorders
|
5 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
General disorders
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Immune system disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Infections and infestations
|
6 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Injury, poisoning and procedural complications
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Investigations
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Metabolism and nutrition disorders
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Musculoskeletal and connective tissue disorders
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Neoplasms benign, malignant and unspecified
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Nervous system disorders
|
3 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Psychiatric disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Reproductive system and breast disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Respiratory, thoracic and mediastinal disorders
|
6 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Skin and subcutaneous tissue disorders
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Vascular disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Panblok 7.5µg in 2% SE
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Panblok 15µg in 2% SE
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Panblok 30µg in 2% SE
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Panblok 30µg (No Adjuvant)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Panblok 7.5µg in 2% SE
n=100 participants at risk
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 15µg in 2% SE
n=101 participants at risk
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg in 2% SE
n=102 participants at risk
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection
|
Panblok 30µg (No Adjuvant)
n=97 participants at risk
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.98%
1/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100 • Day 0 to Week 55
|
0.99%
1/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/100 • Day 0 to Week 55
|
0.99%
1/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Nervous system disorders
Syncope
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.98%
1/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
1.0%
1/97 • Day 0 to Week 55
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.98%
1/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
General disorders
Chest pain
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.98%
1/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Infections and infestations
Appendicitis
|
1.0%
1/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.0%
1/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
1.0%
1/97 • Day 0 to Week 55
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
2/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/100 • Day 0 to Week 55
|
0.99%
1/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.0%
1/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Nervous system disorders
VIIth nerve paralysis
|
1.0%
1/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/100 • Day 0 to Week 55
|
0.99%
1/101 • Day 0 to Week 55
|
0.00%
0/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/100 • Day 0 to Week 55
|
0.00%
0/101 • Day 0 to Week 55
|
0.98%
1/102 • Day 0 to Week 55
|
0.00%
0/97 • Day 0 to Week 55
|
Other adverse events
Adverse event data not reported
Additional Information
Lisa M. Dunkle, M.D., Chief Medical Officer
Protein Sciences Corporation
Phone: 203-599-6064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place