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Trial Outcomes & Findings for Safety Study of Adjuvant Vaccine to Treat Melanoma Patients (NCT NCT01079741)

NCT ID: NCT01079741

Last Updated: 2018-02-13

Results Overview

Safety measured by number of Serious Adverse Events per the CTEP v4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and Dose Limiting Toxicity (DLT).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

52 weeks

Results posted on

2018-02-13

Participant Flow

Participant milestones

Participant milestones
Measure
Poly-ICLC 0.35mg
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.7mg
Cohort 2 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg
Cohort 3 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
NY-ESO-1 Protein and Poly-ICLC
Phase 2, Arm 1 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
NY-ESO-1 Protein, Poly-ICLC and Montanide
Phase 2, Arm 2 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
Cohort 1: Dose Level 1 (Weeks 1-12)
STARTED
3
0
0
0
0
Cohort 1: Dose Level 1 (Weeks 1-12)
COMPLETED
3
0
0
0
0
Cohort 1: Dose Level 1 (Weeks 1-12)
NOT COMPLETED
0
0
0
0
0
Cohort 2: Dose Level 2 (Weeks 13-24)
STARTED
0
4
0
0
0
Cohort 2: Dose Level 2 (Weeks 13-24)
COMPLETED
0
3
0
0
0
Cohort 2: Dose Level 2 (Weeks 13-24)
NOT COMPLETED
0
1
0
0
0
Cohort 3: Dose Level 3 (Weeks 25-36)
STARTED
0
0
3
0
0
Cohort 3: Dose Level 3 (Weeks 25-36)
COMPLETED
0
0
0
0
0
Cohort 3: Dose Level 3 (Weeks 25-36)
NOT COMPLETED
0
0
3
0
0
Phase 2 (Weeks 37-48)
STARTED
0
0
0
12
12
Phase 2 (Weeks 37-48)
COMPLETED
0
0
0
12
9
Phase 2 (Weeks 37-48)
NOT COMPLETED
0
0
0
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Poly-ICLC 0.35mg
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.7mg
Cohort 2 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg
Cohort 3 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
NY-ESO-1 Protein and Poly-ICLC
Phase 2, Arm 1 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
NY-ESO-1 Protein, Poly-ICLC and Montanide
Phase 2, Arm 2 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
Cohort 2: Dose Level 2 (Weeks 13-24)
Disease Progression
0
1
0
0
0
Phase 2 (Weeks 37-48)
Withdrawal by Subject
0
0
0
0
3

Baseline Characteristics

Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Poly-ICLC 0.35 mg
n=3 Participants
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg
n=4 Participants
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg
n=3 Participants
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
NY-ESO-1 Protein and Poly-ICLC
n=12 Participants
100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
NY-ESO-1 Protein, Poly-ICLC and Montanide
n=12 Participants
100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
Total
n=34 Participants
Total of all reporting groups
Age, Continuous
64 years
n=93 Participants
65 years
n=4 Participants
73 years
n=27 Participants
50 years
n=483 Participants
57 years
n=36 Participants
55 years
n=10 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
2 Participants
n=4 Participants
0 Participants
n=27 Participants
5 Participants
n=483 Participants
6 Participants
n=36 Participants
13 Participants
n=10 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
2 Participants
n=4 Participants
3 Participants
n=27 Participants
7 Participants
n=483 Participants
6 Participants
n=36 Participants
21 Participants
n=10 Participants
Pathologic Staging
IIA
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
0 Participants
n=36 Participants
1 Participants
n=10 Participants
Pathologic Staging
IIB
0 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
1 Participants
n=483 Participants
0 Participants
n=36 Participants
2 Participants
n=10 Participants
Pathologic Staging
IIC
1 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
1 Participants
n=36 Participants
2 Participants
n=10 Participants
Pathologic Staging
IIIA
1 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
2 Participants
n=36 Participants
3 Participants
n=10 Participants
Pathologic Staging
IIIB
1 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
4 Participants
n=483 Participants
3 Participants
n=36 Participants
9 Participants
n=10 Participants
Pathologic Staging
IIIC
0 Participants
n=93 Participants
3 Participants
n=4 Participants
2 Participants
n=27 Participants
4 Participants
n=483 Participants
4 Participants
n=36 Participants
13 Participants
n=10 Participants
Pathologic Staging
IV
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
2 Participants
n=483 Participants
2 Participants
n=36 Participants
4 Participants
n=10 Participants

PRIMARY outcome

Timeframe: 52 weeks

Safety measured by number of Serious Adverse Events per the CTEP v4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and Dose Limiting Toxicity (DLT).

Outcome measures

Outcome measures
Measure
Poly-ICLC 0.35 mg
n=3 Participants
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg
n=3 Participants
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg
n=3 Participants
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Phase I, Number of Participants With SAE and DLT
DLT
0 Participants
0 Participants
0 Participants
Phase I, Number of Participants With SAE and DLT
Serious Adverse Events
0 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Cellular response evaluated for the induction of cellular T cell (CD4+ and CD8+) immunity to subcutaneous vaccination with NY-ESO-1 protein in combination with Poly-ICLC when given with or without Montanide. Number of participants with increase CD4+ and CD8+ levels.

Outcome measures

Outcome measures
Measure
Poly-ICLC 0.35 mg
n=12 Participants
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg
n=9 Participants
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
CD4+ and CD8+ Response
CD8 Responder
1 Participants
4 Participants
—
CD4+ and CD8+ Response
CD4 Responder
10 Participants
9 Participants
—

SECONDARY outcome

Timeframe: up to 52 weeks

Analysis of immune cell infiltration at the injection site by IHC. IHC analysis of immune cell infiltration was performed for each arm using a scoring system. 0: No expression of the marker of interest, 1: single cells or small clusters (\<5 cells together) expressing marker of interest, 2: medium size clusters of cells expressing marker of interest, and 3: huge and homogeneously positive clusters of cells expressing marker of interest.

Outcome measures

Outcome measures
Measure
Poly-ICLC 0.35 mg
n=12 Participants
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg
n=9 Participants
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
NY-ESO-1 Expression by IHC
CD20 B cells
0.773 units on a scale
Standard Deviation 0.518
1.500 units on a scale
Standard Deviation 0.500
—
NY-ESO-1 Expression by IHC
CD3 lymphocytes
1.500 units on a scale
Standard Deviation 0.707
1.944 units on a scale
Standard Deviation 0.682
—
NY-ESO-1 Expression by IHC
CD4 lymphocytes
1.318 units on a scale
Standard Deviation 0.643
2.167 units on a scale
Standard Deviation 0.661
—
NY-ESO-1 Expression by IHC
CD8 lymphocytes
1.091 units on a scale
Standard Deviation 0.437
1.222 units on a scale
Standard Deviation 0.565
—
NY-ESO-1 Expression by IHC
CD11c dendritic cells
1.455 units on a scale
Standard Deviation 0.611
2.111 units on a scale
Standard Deviation 0.741
—

Adverse Events

Poly-ICLC 1.4mg

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 2, Arm 1

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Phase 2, Arm 2

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Poly-ICLC 0.35 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Poly-ICLC 0.70 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Poly-ICLC 1.4mg
n=3 participants at risk
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Phase 2, Arm 1
n=12 participants at risk
100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
Phase 2, Arm 2
n=12 participants at risk
100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
Poly-ICLC 0.35 mg
n=3 participants at risk
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg
n=4 participants at risk
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Cardiac disorders
Stent placement
33.3%
1/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
0.00%
0/4

Other adverse events

Other adverse events
Measure
Poly-ICLC 1.4mg
n=3 participants at risk
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Phase 2, Arm 1
n=12 participants at risk
100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
Phase 2, Arm 2
n=12 participants at risk
100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
Poly-ICLC 0.35 mg
n=3 participants at risk
Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg
n=4 participants at risk
100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Blood and lymphatic system disorders
Anemia
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Ear and labyrinth disorders
Tympanic membrane perforation
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/3
8.3%
1/12
0.00%
0/12
33.3%
1/3
0.00%
0/4
Gastrointestinal disorders
Diarrhea
0.00%
0/3
8.3%
1/12
0.00%
0/12
33.3%
1/3
25.0%
1/4
Gastrointestinal disorders
Flatulence
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
50.0%
2/4
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
General disorders
Influenza like illness
33.3%
1/3
75.0%
9/12
66.7%
8/12
100.0%
3/3
50.0%
2/4
General disorders
Injection site erythema
66.7%
2/3
100.0%
12/12
75.0%
9/12
100.0%
3/3
75.0%
3/4
General disorders
Injection site nodule
100.0%
3/3
50.0%
6/12
100.0%
12/12
100.0%
3/3
75.0%
3/4
General disorders
Injection site edema
0.00%
0/3
0.00%
0/12
0.00%
0/12
100.0%
3/3
25.0%
1/4
General disorders
Injection site pain
100.0%
3/3
100.0%
12/12
100.0%
12/12
100.0%
3/3
75.0%
3/4
General disorders
Fatigue
33.3%
1/3
83.3%
10/12
66.7%
8/12
66.7%
2/3
75.0%
3/4
General disorders
Injection site exfoliation
0.00%
0/3
0.00%
0/12
0.00%
0/12
66.7%
2/3
0.00%
0/4
General disorders
Chills
33.3%
1/3
50.0%
6/12
25.0%
3/12
33.3%
1/3
0.00%
0/4
General disorders
Injection site discharge
0.00%
0/3
0.00%
0/12
0.00%
0/12
33.3%
1/3
0.00%
0/4
General disorders
Injection site discomfort
66.7%
2/3
66.7%
8/12
33.3%
4/12
33.3%
1/3
75.0%
3/4
General disorders
Injection site induration
100.0%
3/3
0.00%
0/12
0.00%
0/12
33.3%
1/3
75.0%
3/4
General disorders
Injection site pruritus
33.3%
1/3
50.0%
6/12
58.3%
7/12
33.3%
1/3
75.0%
3/4
General disorders
Injection site vesicles
0.00%
0/3
0.00%
0/12
0.00%
0/12
33.3%
1/3
0.00%
0/4
General disorders
Pain
0.00%
0/3
41.7%
5/12
16.7%
2/12
33.3%
1/3
0.00%
0/4
General disorders
Pyrexia
33.3%
1/3
33.3%
4/12
33.3%
4/12
33.3%
1/3
25.0%
1/4
General disorders
Injection site urticaria
100.0%
3/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
50.0%
2/4
General disorders
Injection site dryness
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
25.0%
1/4
Musculoskeletal and connective tissue disorders
Myalgia
33.3%
1/3
33.3%
4/12
50.0%
6/12
100.0%
3/3
50.0%
2/4
Musculoskeletal and connective tissue disorders
Arthralgia
33.3%
1/3
25.0%
3/12
25.0%
3/12
33.3%
1/3
25.0%
1/4
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/3
0.00%
0/12
0.00%
0/12
33.3%
1/3
0.00%
0/4
Skin and subcutaneous tissue disorders
Rash
33.3%
1/3
8.3%
1/12
16.7%
2/12
33.3%
1/3
25.0%
1/4
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Skin and subcutaneous tissue disorders
Pruritus
33.3%
1/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
25.0%
1/4
Infections and infestations
Ear infection
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Infections and infestations
Rhinitis
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Infections and infestations
Upper respiratory tract infection
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
25.0%
1/4
Reproductive system and breast disorders
Menorrhagia
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Respiratory, thoracic and mediastinal disorders
Productive cough
33.3%
1/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
50.0%
2/4
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3
16.7%
2/12
25.0%
3/12
0.00%
0/3
25.0%
1/4
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
25.0%
1/4
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/3
8.3%
1/12
8.3%
1/12
0.00%
0/3
25.0%
1/4
Respiratory, thoracic and mediastinal disorders
Nasal congestion
33.3%
1/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
33.3%
1/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Respiratory, thoracic and mediastinal disorders
Sinus congestion
33.3%
1/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Surgical and medical procedures
Promotion of wound healing
33.3%
1/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Immune system disorders
Hypersensitivity
33.3%
1/3
0.00%
0/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Injury, poisoning and procedural complications
Postoperative wound complication
33.3%
1/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Cardiac disorders
Coronary artery disease
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Eye disorders
Vision Blurred
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Gastrointestinal disorders
Nausea
0.00%
0/3
25.0%
3/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Gastrointestinal disorders
Dyspepsia
0.00%
0/3
16.7%
2/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Gastrointestinal disorders
Toothache
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
General disorders
Injection site oedema
0.00%
0/3
50.0%
6/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
General disorders
Injection site haemorrhage
0.00%
0/3
16.7%
2/12
16.7%
2/12
0.00%
0/3
0.00%
0/4
General disorders
Chest discomfort
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Immune system disorders
Seasonal allergy
0.00%
0/3
8.3%
1/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Infections and infestations
Nasopharyngitis
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Injury, poisoning and procedural complications
Eye Injury
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Nervous system disorders
Headache
0.00%
0/3
50.0%
6/12
16.7%
2/12
0.00%
0/3
0.00%
0/4
Nervous system disorders
Dizziness
0.00%
0/3
8.3%
1/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Reproductive system and breast disorders
Dysmenorrhoea
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/3
8.3%
1/12
0.00%
0/12
0.00%
0/3
0.00%
0/4
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Gastrointestinal disorders
Abdominal pain
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Infections and infestations
Injection site infection
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Infections and infestations
Staphylococcal infection
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3
0.00%
0/12
16.7%
2/12
0.00%
0/3
0.00%
0/4
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Nervous system disorders
Hypoaesthesia
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Nervous system disorders
Sinus headache
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Psychiatric disorders
Anxiety
0.00%
0/3
0.00%
0/12
16.7%
2/12
0.00%
0/3
0.00%
0/4
Respiratory, thoracic and mediastinal disorders
Nasal dryness
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4
Skin and subcutaneous tissue disorders
Scar
0.00%
0/3
0.00%
0/12
8.3%
1/12
0.00%
0/3
0.00%
0/4

Additional Information

Dr. Nina Bhardwaj

Icahn School of Medicine at Mount Sinai

Phone: 212-824-8427

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place