Trial Outcomes & Findings for Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis (NCT NCT02342691)
NCT ID: NCT02342691
Last Updated: 2023-12-20
Results Overview
Adverse events will be recorded throughout the study, and may include events reported by subjects or changes observed in oral cavity examinations or vital signs (assessed at baseline, Days 3, 7, 14, 21 and 28). Blood and urine will be collected for safety labs at Days 14 and 28 after product administration, and subjects will undergo close monitoring for mucosal inflammation and irritancy and development of periodontitis, using standard clinical periodontal measurements. Follow-up will also occur at 90 days to assess for adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
127 participants
Primary outcome timeframe
up to 90 days
Results posted on
2023-12-20
Participant Flow
Per protocol, 125 subjects were planned to be included in the efficacy population who had a baseline and at least 1 post-baseline assessment of 1 or more of the secondary efficacy outcome measures. Per protocol, subjects who dropped out or withdrew prior to Day 14 were replaced in the efficacy population. Two subjects were dropped out before Day 14, thus were replaced.
Participant milestones
| Measure |
BLXA4-ME Oral Rinse
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
27
|
|
Overall Study
COMPLETED
|
47
|
49
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
Baseline characteristics by cohort
| Measure |
BLXA4-ME Oral Rinse Group
n=50 Participants
The treatment group received daily BLXA4-ME 1μM concentration in an oral rinse
|
Placebo Rinse Group
n=50 Participants
The study group received placebo rinse similar to the rinse used by the treatment group except BLXA4-ME.
|
No-rinse Control Group
n=27 Participants
The study group was a control group with no-rinse.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
27 participants
n=5 Participants
|
127 participants
n=4 Participants
|
|
Modified Gingival Index
|
2.25 units on a scale
STANDARD_DEVIATION 0.141 • n=5 Participants
|
2.30 units on a scale
STANDARD_DEVIATION 0.190 • n=7 Participants
|
2.22 units on a scale
STANDARD_DEVIATION 0.174 • n=5 Participants
|
2.26 units on a scale
STANDARD_DEVIATION 0.171 • n=4 Participants
|
PRIMARY outcome
Timeframe: up to 90 daysAdverse events will be recorded throughout the study, and may include events reported by subjects or changes observed in oral cavity examinations or vital signs (assessed at baseline, Days 3, 7, 14, 21 and 28). Blood and urine will be collected for safety labs at Days 14 and 28 after product administration, and subjects will undergo close monitoring for mucosal inflammation and irritancy and development of periodontitis, using standard clinical periodontal measurements. Follow-up will also occur at 90 days to assess for adverse events.
Outcome measures
| Measure |
BLXA4-ME Oral Rinse
n=50 Participants
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
n=50 Participants
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
n=27 Participants
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Incidence of Adverse Events
|
19 Participants
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The efficacy population consisted of all subjects from the safety population who had a baseline and at least 1 post-baseline assessment of 1 or more of the secondary efficacy outcome measures. Subjects who dropped out or withdrew prior to Day 14 were replaced in the efficacy population. For the efficacy evaluations, subjects were analyzed according to the treatment actually received.
MGI is a visual index used to score gingival inflammation on a scale of 0-4. Higher scores indicate increasing levels of gingival inflammation (worse outcome).
Outcome measures
| Measure |
BLXA4-ME Oral Rinse
n=47 Participants
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
n=49 Participants
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
n=27 Participants
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Change in Mean MGI (Baseline and 28 Days)
|
-0.27 units on a scale
Standard Error 0.029
|
-0.21 units on a scale
Standard Error 0.029
|
-0.17 units on a scale
Standard Error 0.038
|
SECONDARY outcome
Timeframe: 28 daysGingival Bleeding was assessed using the dichotomous bleeding on probing index Bleeding on probing is reported as the percentage of tooth-sites that bleed on probing within a subject and higher BOP values indicate greater gingival inflammation.
Outcome measures
| Measure |
BLXA4-ME Oral Rinse
n=47 Participants
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
n=49 Participants
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
n=27 Participants
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Change in Percent Bleeding on Probing (Baseline and 28 Days)
|
-12.67 percentage of tooth sites
Standard Error 1.59
|
-12.32 percentage of tooth sites
Standard Error 1.588
|
-9.53 percentage of tooth sites
Standard Error 2.14
|
SECONDARY outcome
Timeframe: 28 daysPlaque index (PI) is a visual index used to score (ranging from 0 to 5). A higher score is indicative of higher plaque build-up (worse outcome).
Outcome measures
| Measure |
BLXA4-ME Oral Rinse
n=50 Participants
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
n=48 Participants
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
n=26 Participants
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Change in PI (Baseline and 28 Days)
|
-0.08 units on a scale
Standard Error 0.044
|
-0.12 units on a scale
Standard Error 0.044
|
-0.00 units on a scale
Standard Error 0.060
|
Adverse Events
BLXA4-ME Oral Rinse
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Oral Rinse
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
No Rinse Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLXA4-ME Oral Rinse
n=50 participants at risk
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
n=50 participants at risk
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
n=27 participants at risk
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Adverse Drug Reaction
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
Other adverse events
| Measure |
BLXA4-ME Oral Rinse
n=50 participants at risk
The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution
BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
|
Placebo Oral Rinse
n=50 participants at risk
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Placebo oral rinse: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
|
No Rinse Control
n=27 participants at risk
The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
3/50 • Number of events 3 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
2.0%
1/50 • Number of events 1 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
2/50 • Number of events 2 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Carbon dioxide increased
|
2.0%
1/50 • Number of events 1 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
White blood cell count decreased
|
2.0%
1/50 • Number of events 1 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Blood alkaline phosphatase decreased
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Blood creatinine increased
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Blood urea increased
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Eosinophil count decreased
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Eosinophil count increased
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Neutrophil count decreased
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Occult blood positive
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Protein urine present
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/50 • 3 months
|
0.00%
0/50 • 3 months
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Investigations
White blood cells urine positive
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Gastrointestinal disorders
Oral disorder
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 1 • 3 months
|
4.0%
2/50 • Number of events 2 • 3 months
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Infections and infestations
Hepatitis C
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/50 • 3 months
|
0.00%
0/50 • 3 months
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Number of events 2 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Injury, poisoning and procedural complications
Lip injury
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
General disorders
Adverse drug reaction
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
General disorders
Pyrexia
|
0.00%
0/50 • 3 months
|
0.00%
0/50 • 3 months
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 2 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/50 • 3 months
|
0.00%
0/50 • 3 months
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/50 • 3 months
|
0.00%
0/27 • 3 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50 • 3 months
|
2.0%
1/50 • Number of events 1 • 3 months
|
0.00%
0/27 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place