Trial Outcomes & Findings for Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults (NCT NCT00879814)
NCT ID: NCT00879814
Last Updated: 2015-08-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline up to Month 7
Results posted on
2015-08-06
Participant Flow
Of the 189 participants who signed informed consent form, 134 were screen failures (mainly because of laboratory abnormalities) and 7 participants withdrew before the first vaccination. Total 48 participants were randomized into 4 groups.
Participant milestones
| Measure |
rLP2086 60mcg
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Overall Study
COMPLETED
|
8
|
10
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
3
|
5
|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
Reasons for withdrawal
| Measure |
rLP2086 60mcg
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
2
|
|
Overall Study
Participant Failed to Return
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
Baseline characteristics by cohort
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 7.40 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 7.65 • n=7 Participants
|
27.8 years
STANDARD_DEVIATION 6.05 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 5.77 • n=4 Participants
|
28.8 years
STANDARD_DEVIATION 6.72 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
|
91.7 percentage of participants
|
91.7 percentage of participants
|
91.7 percentage of participants
|
91.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
83.3 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
Baseline: Normal, Post-Baseline: Mild
|
0 percentage of participants
|
8.3 percentage of participants
|
16.7 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Baseline: Normal, Post-Baseline: Mild
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Baseline: Normal, Post-Baseline: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
Baseline:Normal,Post Baseline:Mild/Moderate/Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
Baseline:Normal,Post Baseline:Mild/Moderate/Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
Baseline: Normal, Post-Baseline: Mild
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Baseline: Normal, Post-Baseline: Moderate
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Baseline: Normal, Post-Baseline: Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
91.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Baseline: Normal, Post-Baseline: Mild
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Baseline: Normal, Post-Baseline: Moderate
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Baseline: Normal, Post-Baseline: Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
Baseline: Normal, Post-Baseline: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Baseline: Normal, Post-Baseline: Normal
|
83.3 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Baseline: Normal, Post-Baseline: Mild
|
16.7 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Baseline: Normal, Post-Baseline: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Baseline: Normal, Post-Baseline: Normal
|
83.3 percentage of participants
|
75.0 percentage of participants
|
41.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Baseline: Normal, Post-Baseline: Mild+
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Baseline: Normal, Post-Baseline: Moderate+
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Baseline: Normal, Post-Baseline: Mild-
|
8.3 percentage of participants
|
8.3 percentage of participants
|
25.0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Baseline: Normal, Post-Baseline: Normal
|
75.0 percentage of participants
|
83.3 percentage of participants
|
83.3 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Baseline: Normal, Post-Baseline: Mild
|
16.7 percentage of participants
|
8.3 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Baseline: Normal, Post-Baseline: Moderate
|
8.3 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Baseline: Normal, Post-Baseline: Mild+
|
8.3 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Baseline: Normal, Post-Baseline: Normal
|
91.7 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Baseline: Normal, Post-Baseline: Moderate+
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Baseline: Normal, Post-Baseline: Mild-
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
Baseline: Normal, Post-Baseline: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
Baseline: Normal, Post-Baseline: Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
91.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
Baseline: Normal, Post-Baseline: Mild
|
0 percentage of participants
|
8.3 percentage of participants
|
8.3 percentage of participants
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
Baseline: Normal, Post Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
Baseline:Normal,Post Baseline:Mild/Moderate/Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
91.7 percentage of participants
|
91.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Baseline: Normal, Post-Baseline: Mild+
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Baseline: Normal, Post-Baseline: Moderate+
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Baseline: Normal, Post-Baseline: Severe+
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Baseline: Normal, Post-Baseline: Grade 4 increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Baseline: Normal, Post-Baseline: Normal
|
91.7 percentage of participants
|
75.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Baseline: Normal, Post-Baseline: Mild+
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Baseline: Normal, Post-Baseline: Grade 4 increase
|
8.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
Baseline:Normal,Post Baseline:Mild/Moderate/Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
Baseline:Normal,Post Baseline:Mild/Moderate/Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Baseline: Normal, Post-Baseline: Normal
|
83.3 percentage of participants
|
100.0 percentage of participants
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Baseline: Normal, Post-Baseline: Mild
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Baseline: Normal, Post-Baseline: Moderate
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Baseline: Normal, Post-Baseline: Normal
|
58.3 percentage of participants
|
50.0 percentage of participants
|
58.3 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Baseline: Normal, Post-Baseline: Mild
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Baseline: Normal, Post-Baseline: Moderate
|
25.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Baseline: Normal, Post-Baseline: Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 7Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
Baseline: Normal, Post-Baseline: Normal
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
Baseline:Normal,Post Baseline:Mild/Moderate/Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3Outcome measures
| Measure |
rLP2086 60mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 Participants
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 Participants
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily A: Before Dose 1 (N=12, 12, 12, 12)
|
17.3 titers
Interval 6.3 to 47.8
|
16.8 titers
Interval 6.4 to 43.6
|
7.5 titers
Interval 3.1 to 17.8
|
7.9 titers
Interval 3.4 to 18.2
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily B: 1 Month After dose 3 (N=8, 10, 9, 7)
|
2081.9 titers
Interval 1098.1 to 3947.1
|
2295.3 titers
Interval 1224.2 to 4303.5
|
3445.0 titers
Interval 1544.9 to 7682.2
|
2.6 titers
Interval 1.0 to 6.8
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily A: 1 Month After Dose2 (N=10, 12, 11, 9)
|
1522.7 titers
Interval 817.5 to 2836.0
|
1933.5 titers
Interval 1036.3 to 3607.6
|
1132.7 titers
Interval 575.0 to 2231.1
|
3.1 titers
Interval 1.7 to 5.5
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily A: Before Dose 3 (N=10, 11, 11, 7)
|
495.7 titers
Interval 238.0 to 1032.4
|
500.7 titers
Interval 253.6 to 988.7
|
318.6 titers
Interval 147.4 to 688.5
|
3.5 titers
Interval 1.6 to 7.8
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily A: 1 Month After Dose 3 (N=8, 10, 9, 7)
|
4107.4 titers
Interval 1752.3 to 9627.6
|
4326.9 titers
Interval 2214.5 to 8454.2
|
2664.8 titers
Interval 1410.8 to 5033.4
|
3.8 titers
Interval 2.1 to 6.7
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily B: Before Dose 1 (N=12, 12, 12, 12)
|
15.6 titers
Interval 6.1 to 40.2
|
7.1 titers
Interval 2.9 to 17.5
|
8.8 titers
Interval 4.0 to 19.5
|
5.1 titers
Interval 2.2 to 12.0
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily B: 1 Month After Dose2 (N=10, 12, 11, 9)
|
850.5 titers
Interval 547.1 to 1322.2
|
1071.2 titers
Interval 641.4 to 1789.0
|
1300.9 titers
Interval 692.5 to 2443.6
|
2.8 titers
Interval 1.1 to 7.2
|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Subfamily B: Before Dose3 (N=10, 11, 11, 7)
|
289.8 titers
Interval 168.0 to 499.8
|
361.4 titers
Interval 192.7 to 677.6
|
370.2 titers
Interval 145.7 to 940.6
|
3.1 titers
Interval 1.1 to 8.8
|
Adverse Events
rLP2086 60mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
rLP2086 120 mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
rLP2086 200 mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Tdap/Normal Saline (Control)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rLP2086 60mcg
n=12 participants at risk
Given on a 0, 2-, 6- month schedule
|
rLP2086 120 mcg
n=12 participants at risk
Given on a 0, 2-, 6- month schedule
|
rLP2086 200 mcg
n=12 participants at risk
Given on a 0, 2-, 6- month schedule
|
Tdap/Normal Saline (Control)
n=12 participants at risk
Tdap was given at month 0 and Saline was given at Month 2 and 6
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Induration
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site induration
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pruritus
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site rash
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Food allergy
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
6/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
41.7%
5/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
6/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood fibrinogen decreased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood fibrinogen increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
6/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood sodium increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Fibrin D dimer increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
4/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haematocrit decreased
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Mean cell haemoglobin decreased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count increased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein urine
|
41.7%
5/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
6/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
41.7%
5/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cell count decreased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cells urine
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red cell distribution width increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count increased
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
4/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER