Trial Outcomes & Findings for Mast Cell Activation Test in Allergic Disease (NCT NCT03406325)
NCT ID: NCT03406325
Last Updated: 2020-04-09
Results Overview
Mast Cell Activation Test results of high/low level of house dust mite sensitivity by using normal donor cultured mast cells for validation.
Recruitment status
COMPLETED
Target enrollment
19 participants
Primary outcome timeframe
Mast cells studied after 9 weeks in culture
Results posted on
2020-04-09
Participant Flow
19 patients were recruited in the study. 12 were used for validation. 7 were used for patient-specific testing. Therefore, there were 1 validation group and 7 individuals' result.
Participant milestones
| Measure |
Validation Group
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
|
SH#2
Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
|
SH#3
Female patient, Total IgE: 5333KU/L; Der p2IgE: \>100KU/L; clinical diagnosis: Eczema
|
SH#4
Male patient, Total IgE: 4070KU/L; Der p2IgE: \>100KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
Female patient, Total IgE: 13KU/L; Der p2IgE: \<0.1KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
12
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mast Cell Activation Test in Allergic Disease
Baseline characteristics by cohort
| Measure |
Validation Group
n=12 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
n=1 Participants
Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema
|
SH#2
n=1 Participants
Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema
|
SH#3
n=1 Participants
Female patient, Total IgE: 5333KU/L; Der p2IgE: \>100KU/L; clinical diagnosis: Eczema
|
SH#4
n=1 Participants
Male patient, Total IgE: 4070KU/L; Der p2IgE: \>100KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
n=1 Participants
Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
n=1 Participants
Female patient, Total IgE: 13KU/L; Der p2IgE: \<0.1KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
n=1 Participants
Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria
|
Total
n=19 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
19 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
18 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Hong Kong
|
12 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
7 participants
n=42 Participants
|
|
Clinical diagnosis
Eczema
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Clinical diagnosis
Rhinitis
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Clinical diagnosis
Urticaria
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Clinical diagnosis
Exercise-induced anaphylaxis
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Clinical diagnosis
Mast cell activation syndrome
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Clinical diagnosis
Eczema and Urticaria
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Mast cells studied after 9 weeks in culturePopulation: Mast cells were cultured from blood of normal donors to validate the (Mast Cell Activation) MAT assay. The serum samples were obtained from allergic patients with sensitivities to Der p2 and used for passive sensitization of normal donor mast cells followed by their activation by Der p2 allergen. Data were collected only from the validation group.
Mast Cell Activation Test results of high/low level of house dust mite sensitivity by using normal donor cultured mast cells for validation.
Outcome measures
| Measure |
Validation Group
n=12 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
|
SH#2
Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
|
SH#3
Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema
|
SH#4
Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Mast Cell Activation Test Results for Validation Group
High level of house dust mite sensitivity · MAT positive
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mast Cell Activation Test Results for Validation Group
High level of house dust mite sensitivity · MAT negative
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mast Cell Activation Test Results for Validation Group
Low level of house dust mite sensitivity · MAT positive
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mast Cell Activation Test Results for Validation Group
Low level of house dust mite sensitivity · MAT negative
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Mast cells studied after 9 weeks in culturePopulation: Serum samples were obtained from 19 patients in total, of whom 12 were in the validation group. The other 7 patients were studied more extensively in the trial and their data is reported individually in this section and thereafter.
Patient's serum was incubated with mast cells derived from normal donors for detection of mast cell activation as evidenced by histamine release.
Outcome measures
| Measure |
Validation Group
n=12 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
n=1 Participants
Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
|
SH#2
n=1 Participants
Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
|
SH#3
n=1 Participants
Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema
|
SH#4
n=1 Participants
Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
n=1 Participants
Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
n=1 Participants
Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
n=1 Participants
Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Mast cells studied after 9 weeks in culturePopulation: Mast cells derived from the validation group is reported as a group (mean +/-SD). The other 7 allergic patients were analysed and reported individually as explained earlier.
percentage of total histamine release by normal average responder mast cells that had been activated with patient's serum
Outcome measures
| Measure |
Validation Group
n=12 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
n=1 Participants
Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
|
SH#2
n=1 Participants
Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
|
SH#3
n=1 Participants
Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema
|
SH#4
n=1 Participants
Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
n=1 Participants
Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
n=1 Participants
Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
n=1 Participants
Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Histamine Release by Normal Average Responder Mast Cells + Patient's Serum to Assess Autoreactivity
|
2.15 percentage of histamine released
Standard Deviation 0.71
|
32.1 percentage of histamine released
|
3.3 percentage of histamine released
|
2.8 percentage of histamine released
|
3.4 percentage of histamine released
|
5.1 percentage of histamine released
|
3.2 percentage of histamine released
|
3.8 percentage of histamine released
|
PRIMARY outcome
Timeframe: Mast cells studied after 9 weeks in culturePopulation: Mast cells derived from 7 allergic patients were analysed and reported individually. Patients in the validation group were not measured for this outcome and their samples were only used to validate the assay.
percentage of total histamine release by patient's mast cells that had been activated with anti-IgE
Outcome measures
| Measure |
Validation Group
n=1 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
n=1 Participants
Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
|
SH#2
n=1 Participants
Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
|
SH#3
n=1 Participants
Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema
|
SH#4
n=1 Participants
Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
n=1 Participants
Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
n=1 Participants
Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Histamine Release by Patient's Mast Cells + Immunoglobulin E (IgE)/Anti-IgE
|
11.5 percentage of histamine release
|
38.3 percentage of histamine release
|
69.6 percentage of histamine release
|
47.9 percentage of histamine release
|
36.3 percentage of histamine release
|
45.5 percentage of histamine release
|
41.6 percentage of histamine release
|
—
|
PRIMARY outcome
Timeframe: Mast cells studied after 9 weeks in culturePopulation: Mast cells derived from 7 allergic patients were analysed and reported individually. Patients in the validation group were not measured for this outcome and their samples were only used to validate the assay.
Percentage of total histamine release when patient's mast cells were activated with patient's own serum and Der p2. Each patient's results are reported individually.
Outcome measures
| Measure |
Validation Group
n=1 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
n=1 Participants
Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
|
SH#2
n=1 Participants
Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
|
SH#3
n=1 Participants
Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema
|
SH#4
n=1 Participants
Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
n=1 Participants
Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
n=1 Participants
Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Histamine Release by Patient's Mast Cells + Patient's Serum + Allergen
|
24.5 percentage of histamine release
|
54.7 percentage of histamine release
|
79 percentage of histamine release
|
8.4 percentage of histamine release
|
0.2 percentage of histamine release
|
0.2 percentage of histamine release
|
0 percentage of histamine release
|
—
|
PRIMARY outcome
Timeframe: Mast cells studied after 9 weeks in culturePopulation: Mast cells derived from 7 allergic patients were analysed and reported individually. Patients in the validation group were not measured for this outcome and their samples were only used to validate the assay.
Cell yield of patient's mast cell culture after 9 weeks in culture as an index of cell growth and differentiation.
Outcome measures
| Measure |
Validation Group
n=1 Participants
Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples
|
SH#1
n=1 Participants
Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema
|
SH#2
n=1 Participants
Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema
|
SH#3
n=1 Participants
Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema
|
SH#4
n=1 Participants
Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria
|
SH#5
n=1 Participants
Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis
|
SH#6
n=1 Participants
Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome
|
SH#7
Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria
|
|---|---|---|---|---|---|---|---|---|
|
Cell Yield Per 100ml Blood
|
14045000 Cell yield per 100ml blood
|
2895522 Cell yield per 100ml blood
|
115294 Cell yield per 100ml blood
|
625263 Cell yield per 100ml blood
|
4867778 Cell yield per 100ml blood
|
352000 Cell yield per 100ml blood
|
1400000 Cell yield per 100ml blood
|
—
|
Adverse Events
Validation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SH#7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place