Trial Outcomes & Findings for Mechanism of Action Study for Psoriasis (NCT NCT00932113)
NCT ID: NCT00932113
Last Updated: 2017-08-31
Results Overview
Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Weeks 0, 1, 2, 4 and 16
Results posted on
2017-08-31
Participant Flow
The discrepancy between the enrollment number in the protocol section and number of participants in participant flow module is due to 3 participants screen failing and being allowed to re-screen. We counted them as enrolled upon signing of new consent and conducting re-screening visit.
Participant milestones
| Measure |
Adalimumab
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Adalimumab
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Mechanism of Action Study for Psoriasis
Baseline characteristics by cohort
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
50.5 years
n=99 Participants
|
50.3 years
n=107 Participants
|
50.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
caucasian
|
12 participants
n=99 Participants
|
14 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
african american
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
unknown
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 1, 2, 4 and 16Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.
Outcome measures
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Biologic Activity Endpoints
CAMP(responders)
|
-3.85 fold change
Standard Error 0.79
|
-2.83 fold change
Standard Error 0.82
|
|
Biologic Activity Endpoints
CAMP(Non responders)
|
0.05 fold change
Standard Error 2.2
|
0.84 fold change
Standard Error 0.60
|
|
Biologic Activity Endpoints
CCL20 (responders)
|
-3.55 fold change
Standard Error 0.54
|
-2.96 fold change
Standard Error 0.51
|
|
Biologic Activity Endpoints
CCL20 (non responders)
|
0.84 fold change
Standard Error 1.5
|
0.84 fold change
Standard Error 0.6
|
|
Biologic Activity Endpoints
CXCL1 (responders)
|
-3.01 fold change
Standard Error 0.61
|
-3.18 fold change
Standard Error 0.7
|
|
Biologic Activity Endpoints
CXCL1 (non responders)
|
1.03 fold change
Standard Error 1.6
|
1.22 fold change
Standard Error 0.83
|
|
Biologic Activity Endpoints
DEFB4A (responders)
|
-6.96 fold change
Standard Error 0.96
|
-6 fold change
Standard Error 1.1
|
|
Biologic Activity Endpoints
DEFB4A (non responders)
|
-0.07 fold change
Standard Error 2.6
|
1.83 fold change
Standard Error 1.2
|
|
Biologic Activity Endpoints
IL 17F (responders)
|
-1.97 fold change
Standard Error 0.99
|
-3.24 fold change
Standard Error 0.74
|
|
Biologic Activity Endpoints
IL 17F (non responders)
|
0.79 fold change
Standard Error 2.8
|
1.02 fold change
Standard Error .87
|
|
Biologic Activity Endpoints
IL 17A (responders)
|
-5.31 fold change
Standard Error 0.98
|
-4.75 fold change
Standard Error .96
|
|
Biologic Activity Endpoints
IL 17A (non responders)
|
0.18 fold change
Standard Error 2.8
|
1.00 fold change
Standard Error 1.1
|
|
Biologic Activity Endpoints
IL 23 A (responders)
|
-3.90 fold change
Standard Error 0.79
|
-2.72 fold change
Standard Error 0.56
|
|
Biologic Activity Endpoints
IL 23A (non responders)
|
-0.81 fold change
Standard Error 2.2
|
0.89 fold change
Standard Error 0.67
|
|
Biologic Activity Endpoints
IL 22 (responders)
|
-3.58 fold change
Standard Error 1.0
|
-5.14 fold change
Standard Error 0.68
|
|
Biologic Activity Endpoints
IL 22 (non rsponders)
|
0.25 fold change
Standard Error 2.8
|
1.00 fold change
Standard Error 0.80
|
|
Biologic Activity Endpoints
IFNG (responders)
|
-2.66 fold change
Standard Error 0.77
|
-1.77 fold change
Standard Error 0.61
|
|
Biologic Activity Endpoints
IFNG (non responders)
|
-0.52 fold change
Standard Error 2.2
|
0.82 fold change
Standard Error 0.72
|
|
Biologic Activity Endpoints
MX1 (responders)
|
-1.90 fold change
Standard Error 0.31
|
-2.00 fold change
Standard Error 0.46
|
|
Biologic Activity Endpoints
MX1 (non responders)
|
0.04 fold change
Standard Error 0.86
|
0.47 fold change
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Weeks 0 and week 16PASI 75 is the percent of subjects who experience an improvement in PASI (Psoriasis Area and Severity Index) score of at least 75% from their baseline PASI score.
Outcome measures
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Clinical Endpoints for Psoriasis: PASI 75
|
67 percentage of subjects
|
27 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Outcome measures
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)
|
73 percentage of subjects
|
27 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0 and week 16Outcome measures
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Clinical Endpoints for Psoriasis: % Body Surface Area
|
5.9 percentage of total body surface area
Interval 0.0 to 25.0
|
10.7 percentage of total body surface area
Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: Week 0 and Week 16The lesion score of a single psoriatic plaque selected at baseline. Total range is 0 - 12 with 0 being clear and 12 representing the most severe disease. The target lesion score is composed of scale, erythema, and induration, each parameter is scored 0 (clear) through 4 (very severe). Totals are summed for target lesion score. S+E+I = TLS
Outcome measures
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Clinical Endpoints for Psoriasis: Target Lesion Score
|
1.2 units on a scale
Interval 0.0 to 8.5
|
3.4 units on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Week 0 and Week 16Outcome measures
| Measure |
Adalimumab
n=15 Participants
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 Participants
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Clinical Endpoints for Psoriasis: Photography Completed
|
15 participants
|
15 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: long-term follow-up visit 4- 6 years post end of studyA single, long-term follow-up visit will be done for all available subjects for additional pharmacogenetic analysis. The goal in collecting DNA from psoriasis patients is to determine if individual subjects have gene variants associated with increased incidence of psoriasis. The investigators plan on analyzing variants using single nucleotide polymorphism (SNP) analysis by high-throughput DNA sequencing. This patient genetic information may allow us to correctly interpret data collected about gene expression levels in affected or non-affected skin. Additionally genetic typing may lead to cogent personalized health care (PHC) strategies for the identification of psoriasis drug responders/non-responders, patients who achieve durable disease remission post-treatment, and/or pharmacodynamic markers, as examples.
Outcome measures
Outcome data not reported
Adverse Events
Adalimumab
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Methotrexate (MTX)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adalimumab
n=15 participants at risk
Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
|
Methotrexate (MTX)
n=15 participants at risk
Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15
|
20.0%
3/15 • Number of events 5
|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Biopsy Site Infection
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Flu-Like Symptoms
|
13.3%
2/15 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Acute Paronychia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Viral Gastroenteritis
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
40.0%
6/15 • Number of events 10
|
40.0%
6/15 • Number of events 7
|
|
Infections and infestations
Upper Respiratory Tract Infection/Bronchitis
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epidermal Inclusion Cyst
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Surgical and medical procedures
Biopsy of Nevi
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Oral Apthous Ulcer
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dislocated Thumb
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Strain
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Fatigue
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Irritant Contact Dermatitis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Surgical and medical procedures
Liquid Nitrogen to Skin Tag
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Mood Swings
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back Spasm
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Injection Site Reaction/Myalgias
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Bruise/abrasions s/p fall
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Finger Laceration
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Ecchymoses near injection site
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Ecchymoses near biopsy site
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Dysesthesias
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place