Trial Outcomes & Findings for Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease (NCT NCT00959192)
NCT ID: NCT00959192
Last Updated: 2016-01-01
Results Overview
Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Baseline up to 24 months
Results posted on
2016-01-01
Participant Flow
Participant milestones
| Measure |
ACC-001 3 Micrograms + QS-21
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
9
|
8
|
|
Overall Study
COMPLETED
|
4
|
8
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
ACC-001 3 Micrograms + QS-21
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
|
Overall Study
Investigator Request
|
1
|
0
|
0
|
0
|
|
Overall Study
Caregiver Request
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.50 years
STANDARD_DEVIATION 8.73 • n=39 Participants
|
68.00 years
STANDARD_DEVIATION 10.34 • n=41 Participants
|
74.33 years
STANDARD_DEVIATION 6.69 • n=35 Participants
|
64.75 years
STANDARD_DEVIATION 7.15 • n=31 Participants
|
69.81 years
STANDARD_DEVIATION 8.83 • n=146 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
25 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 24 monthsPopulation: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Mild
|
4 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Moderate
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 24 monthsPopulation: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Abnormal - inconsistent with AD
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Abnormal - consistent with AD
|
6 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 24 monthsPopulation: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Neurological Examination
Total
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Mental Status
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Speech
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Cranial Nerves
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Visual Field
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Sensory
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Motor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Coordination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Gate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Primitive reflexes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Tendon reflexes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Neurological Examination
Romberg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 monthsPopulation: The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Anti-a-beta IgG Titer at Specified Visits
Pre-study (n=6,9,9,8)
|
50.0 Units/mL
Interval 50.0 to 50.0
|
50.0 Units/mL
Interval 50.0 to 50.0
|
50.0 Units/mL
Interval 50.0 to 50.0
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 2 (n=6,9,9,8)
|
62.2 Units/mL
Interval 35.5 to 109.3
|
65.0 Units/mL
Interval 35.5 to 118.9
|
67.0 Units/mL
Interval 34.1 to 131.8
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 4 (n=6,9,9,8)
|
107.9 Units/mL
Interval 30.3 to 384.4
|
94.2 Units/mL
Interval 40.1 to 221.1
|
79.0 Units/mL
Interval 27.5 to 227.1
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 6 (n=6,9,9,8)
|
2106.5 Units/mL
Interval 141.7 to 31312.7
|
4793.2 Units/mL
Interval 1261.0 to 18220.0
|
5702.6 Units/mL
Interval 1181.1 to 17288.0
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 8 (n=6,9,9,8)
|
1143.3 Units/mL
Interval 108.0 to 12104.3
|
2331.4 Units/mL
Interval 512.2 to 10612.3
|
3423.9 Units/mL
Interval 1182.1 to 9917.0
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 10 (n=6,9,9,8)
|
979.2 Units/mL
Interval 96.8 to 9903.1
|
1674.9 Units/mL
Interval 369.5 to 7592.9
|
2012.4 Units/mL
Interval 643.4 to 6294.9
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 14 (n=6,9,9,8)
|
6088.4 Units/mL
Interval 714.5 to 51878.2
|
6286.2 Units/mL
Interval 3923.5 to 10071.6
|
9983.5 Units/mL
Interval 2820.9 to 35333.3
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 16 (n=6,9,9,8)
|
3860.4 Units/mL
Interval 342.5 to 43507.1
|
4170.4 Units/mL
Interval 2641.8 to 6583.4
|
9228.0 Units/mL
Interval 2930.5 to 29058.2
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 24 (n=6,9,9,8)
|
1151.5 Units/mL
Interval 165.8 to 7998.4
|
1455.0 Units/mL
Interval 936.2 to 2261.1
|
3903.1 Units/mL
Interval 1151.8 to 13226.8
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 28 (n=6,9,7,8)
|
8216.5 Units/mL
Interval 1550.5 to 43541.2
|
8929.3 Units/mL
Interval 4466.9 to 17849.8
|
7429.5 Units/mL
Interval 3925.7 to 14060.5
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 30 (n=6,9,7,8)
|
7218.7 Units/mL
Interval 1438.9 to 36213.5
|
7017.4 Units/mL
Interval 3510.7 to 14026.7
|
6162.2 Units/mL
Interval 3062.2 to 12400.6
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 40 (n=5,9,8,8)
|
3136.4 Units/mL
Interval 651.2 to 15106.7
|
2706.5 Units/mL
Interval 1358.1 to 5393.9
|
3615.5 Units/mL
Interval 1145.5 to 11411.2
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 50 (n=6,8,7,8)
|
1854.5 Units/mL
Interval 558.3 to 6159.4
|
1255.8 Units/mL
Interval 656.3 to 2402.9
|
1261.4 Units/mL
Interval 699.2 to 2275.9
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 54 (n=5,8,7,7)
|
2873.6 Units/mL
Interval 264.8 to 31178.1
|
9636.4 Units/mL
Interval 4558.5 to 20370.7
|
8604.6 Units/mL
Interval 4030.7 to 18368.8
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 56 (n=4,8,7,7)
|
11006.2 Units/mL
Interval 1617.8 to 74878.3
|
7582.4 Units/mL
Interval 3143.9 to 18286.8
|
6201.5 Units/mL
Interval 2921.4 to 13164.5
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 66 (n=4,8,7,7)
|
7407.9 Units/mL
Interval 1127.0 to 48693.5
|
3942.5 Units/mL
Interval 1539.4 to 10096.9
|
2452.5 Units/mL
Interval 1442.5 to 4169.7
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 78 (n=4,8,6,7)
|
5108.6 Units/mL
Interval 1013.9 to 25739.1
|
2465.3 Units/mL
Interval 961.9 to 6318.5
|
1316.3 Units/mL
Interval 645.0 to 2686.1
|
50.0 Units/mL
Interval 50.0 to 50.0
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 91 (n=0,1,1,0)
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
546.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
389.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
|
Anti-a-beta IgG Titer at Specified Visits
Week 104 (n=0,1,1,0)
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
414.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
285.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
SECONDARY outcome
Timeframe: Baseline up to 24 monthsPopulation: The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.
Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Anti-a-beta IgM Titer at Specified Visits
Week 66 (n=4,8,7,7)
|
1213.0 Units/mL
Interval 244.1 to 6027.2
|
1872.7 Units/mL
Interval 523.3 to 6701.7
|
1825.1 Units/mL
Interval 346.2 to 9621.6
|
46.0 Units/mL
Interval 20.2 to 104.4
|
|
Anti-a-beta IgM Titer at Specified Visits
Pre-study (n=6,9,9,8)
|
30.9 Units/mL
Interval 17.9 to 53.6
|
28.2 Units/mL
Interval 21.3 to 37.4
|
25.0 Units/mL
Interval 25.0 to 25.0
|
41.5 Units/mL
Interval 21.8 to 78.8
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 2 (n=6,9,9,8)
|
77.1 Units/mL
Interval 17.1 to 347.0
|
92.0 Units/mL
Interval 31.7 to 266.6
|
53.5 Units/mL
Interval 22.5 to 127.6
|
42.4 Units/mL
Interval 21.6 to 83.3
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 4 (n=6,9,9,8)
|
108.5 Units/mL
Interval 19.4 to 605.6
|
141.5 Units/mL
Interval 41.6 to 481.5
|
108.5 Units/mL
Interval 41.0 to 286.9
|
43.7 Units/mL
Interval 21.6 to 88.3
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 6 (n=6,9,9,8)
|
953.2 Units/mL
Interval 95.7 to 9493.1
|
2988.4 Units/mL
Interval 879.2 to 10157.9
|
2381.4 Units/mL
Interval 662.7 to 8556.9
|
43.0 Units/mL
Interval 21.6 to 85.9
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 8 (n=6,9,9,8)
|
848.6 Units/mL
Interval 85.6 to 8414.6
|
2940.1 Units/mL
Interval 812.5 to 10639.6
|
2776.2 Units/mL
Interval 622.2 to 12386.2
|
46.9 Units/mL
Interval 23.7 to 92.9
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 10 (n=6,9,9,8)
|
850.8 Units/mL
Interval 147.5 to 4907.8
|
2432.1 Units/mL
Interval 661.4 to 8943.5
|
2323.9 Units/mL
Interval 482.5 to 11192.7
|
36.1 Units/mL
Interval 19.1 to 68.2
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 14 (n=6,9,9,8)
|
1487.6 Units/mL
Interval 288.1 to 7682.0
|
2231.0 Units/mL
Interval 728.6 to 6831.2
|
4438.5 Units/mL
Interval 1000.5 to 19689.6
|
37.6 Units/mL
Interval 19.6 to 72.3
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 16 (n=6,9,9,8)
|
1503.2 Units/mL
Interval 254.5 to 8880.8
|
2484.8 Units/mL
Interval 797.6 to 7740.9
|
4590.6 Units/mL
Interval 1041.7 to 20230.3
|
40.5 Units/mL
Interval 18.4 to 89.5
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 24 (n=6,9,9,8)
|
898.5 Units/mL
Interval 222.1 to 3634.1
|
1421.8 Units/mL
Interval 442.7 to 4565.8
|
2396.4 Units/mL
Interval 643.2 to 8928.8
|
40.1 Units/mL
Interval 18.4 to 87.1
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 28 (n=6,9,7,8)
|
885.9 Units/mL
Interval 240.0 to 3270.2
|
3395.8 Units/mL
Interval 1356.5 to 8500.9
|
3592.8 Units/mL
Interval 628.7 to 20531.3
|
42.1 Units/mL
Interval 21.3 to 83.3
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 30 (n=6,9,7,8)
|
859.5 Units/mL
Interval 273.2 to 2704.0
|
3729.9 Units/mL
Interval 1286.6 to 10812.9
|
2956.7 Units/mL
Interval 636.6 to 13732.9
|
38.9 Units/mL
Interval 19.4 to 78.2
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 40 (n=5,9,8,8)
|
449.0 Units/mL
Interval 110.4 to 1825.7
|
2480.5 Units/mL
Interval 760.2 to 8093.8
|
1967.3 Units/mL
Interval 421.5 to 9183.1
|
37.8 Units/mL
Interval 19.2 to 74.4
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 50 (n=6,8,7,8)
|
354.2 Units/mL
Interval 75.6 to 1659.4
|
1330.0 Units/mL
Interval 388.5 to 4553.3
|
1326.8 Units/mL
Interval 233.3 to 7546.2
|
39.9 Units/mL
Interval 17.9 to 88.8
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 54 (n=5,8,7,7)
|
680.7 Units/mL
Interval 120.0 to 3861.3
|
2605.4 Units/mL
Interval 862.1 to 7874.2
|
3017.0 Units/mL
Interval 678.8 to 13408.9
|
48.3 Units/mL
Interval 19.2 to 121.1
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 56 (n=4,8,7,7)
|
1768.3 Units/mL
Interval 342.4 to 9132.4
|
2570.6 Units/mL
Interval 794.2 to 8320.4
|
3051.9 Units/mL
Interval 618.2 to 15066.0
|
40.5 Units/mL
Interval 16.4 to 100.0
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 78 (n=4,8,6,7)
|
952.8 Units/mL
Interval 251.0 to 3617.1
|
1650.3 Units/mL
Interval 491.4 to 5542.5
|
844.9 Units/mL
Interval 155.4 to 4594.7
|
48.3 Units/mL
Interval 19.0 to 122.8
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 91 (n=0,1,1,0)
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
219.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
351.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
|
Anti-a-beta IgM Titer at Specified Visits
Week 104 (n=0,1,1,0)
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
154.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
258.0 Units/mL
95% confidence interval was not estimable since only one participant was evaluable.
|
NA Units/mL
Data were not analyzed as no participants were evaluable for the particular week.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 monthsPopulation: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Week 12 (n=6,9,9,8)
|
0.06 Units on a scale
Standard Deviation 5.20
|
0.52 Units on a scale
Standard Deviation 4.39
|
2.93 Units on a scale
Standard Deviation 4.10
|
-0.25 Units on a scale
Standard Deviation 3.30
|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Week 26 (n=6,9,9,8)
|
0.39 Units on a scale
Standard Deviation 4.38
|
-0.41 Units on a scale
Standard Deviation 5.41
|
3.56 Units on a scale
Standard Deviation 6.74
|
-0.63 Units on a scale
Standard Deviation 5.76
|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Week 52 (n=5,9,7,8)
|
1.87 Units on a scale
Standard Deviation 8.32
|
0.15 Units on a scale
Standard Deviation 4.82
|
5.05 Units on a scale
Standard Deviation 6.68
|
1.04 Units on a scale
Standard Deviation 7.01
|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Week 78 (n=4,8,6,7)
|
0.17 Units on a scale
Standard Deviation 3.50
|
3.40 Units on a scale
Standard Deviation 7.08
|
5.39 Units on a scale
Standard Deviation 3.66
|
2.33 Units on a scale
Standard Deviation 7.78
|
|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Week 104 (n=0,1,1,0)
|
NA Units on a scale
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
-4.33 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
8.33 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
NA Units on a scale
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 monthsPopulation: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=8 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Week 12 (n=5,9,7,8)
|
-4.7 Units on a scale
Standard Deviation 9.7
|
0.7 Units on a scale
Standard Deviation 2.6
|
1.5 Units on a scale
Standard Deviation 5.1
|
1.7 Units on a scale
Standard Deviation 6.4
|
|
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Week 26 (n=6,9,8,8)
|
-10.1 Units on a scale
Standard Deviation 14.5
|
-0.2 Units on a scale
Standard Deviation 11.9
|
-4.4 Units on a scale
Standard Deviation 28.6
|
-0.6 Units on a scale
Standard Deviation 6.5
|
|
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Week 52 (n=5,8,6,8)
|
-11.2 Units on a scale
Standard Deviation 20.9
|
-3.4 Units on a scale
Standard Deviation 10.7
|
-1.8 Units on a scale
Standard Deviation 5.1
|
-3.1 Units on a scale
Standard Deviation 9.0
|
|
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Week 78 (n=4,8,5,6)
|
-0.6 Units on a scale
Standard Deviation 3.1
|
-5.4 Units on a scale
Standard Deviation 7.7
|
0.5 Units on a scale
Standard Deviation 6.9
|
3.5 Units on a scale
Standard Deviation 3.2
|
|
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Week 104 (n=0,1,1,0)
|
NA Units on a scale
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
12.8 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
NA Units on a scale
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 monthsPopulation: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\_visit - y\_base)/SD\_base, where y\_visit is a value at a particular time point and y\_base is the average test score, and SD\_base is the SD based on all participants' observed baseline scores in the study.
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Week 12 (n=6,9,8,8)
|
0.023 Z-score
Standard Deviation 0.416
|
0.275 Z-score
Standard Deviation 0.280
|
-0.028 Z-score
Standard Deviation 0.282
|
0.227 Z-score
Standard Deviation 0.107
|
|
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Week 26 (n=6,9,9,8)
|
0.114 Z-score
Standard Deviation 0.423
|
0.254 Z-score
Standard Deviation 0.353
|
-0.081 Z-score
Standard Deviation 0.530
|
0.222 Z-score
Standard Deviation 0.308
|
|
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Week 52 (n=5,9,7,8)
|
0.081 Z-score
Standard Deviation 0.288
|
0.211 Z-score
Standard Deviation 0.285
|
-0.109 Z-score
Standard Deviation 0.263
|
0.213 Z-score
Standard Deviation 0.416
|
|
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Week 78 (n=4,8,6,7)
|
-0.088 Z-score
Standard Deviation 0.334
|
-0.037 Z-score
Standard Deviation 0.494
|
-0.120 Z-score
Standard Deviation 0.442
|
0.246 Z-score
Standard Deviation 0.336
|
|
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Week 104 (n=0,1,1,0)
|
NA Z-score
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
0.514 Z-score
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-0.559 Z-score
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
NA Z-score
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 monthsPopulation: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.
Outcome measures
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 Participants
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 Participants
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 Participants
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 4 (n=6,9,9,8)
|
1.7 Units on a scale
Standard Deviation 1.5
|
1.3 Units on a scale
Standard Deviation 1.7
|
1.6 Units on a scale
Standard Deviation 2.7
|
0.4 Units on a scale
Standard Deviation 2.3
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 8 (n=6,9,9,8)
|
2.2 Units on a scale
Standard Deviation 3.1
|
0.9 Units on a scale
Standard Deviation 3.2
|
1.3 Units on a scale
Standard Deviation 1.7
|
0.9 Units on a scale
Standard Deviation 2.6
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 12 (n=6,9,9,8)
|
0.8 Units on a scale
Standard Deviation 2.8
|
1.1 Units on a scale
Standard Deviation 2.7
|
1.1 Units on a scale
Standard Deviation 2.0
|
1.4 Units on a scale
Standard Deviation 2.7
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 16 (n=6,9,9,8)
|
1.5 Units on a scale
Standard Deviation 3.4
|
1.3 Units on a scale
Standard Deviation 2.3
|
2.9 Units on a scale
Standard Deviation 2.5
|
0.4 Units on a scale
Standard Deviation 1.8
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 26 (n=6,9,8,8)
|
0.3 Units on a scale
Standard Deviation 3.8
|
0.1 Units on a scale
Standard Deviation 2.6
|
1.0 Units on a scale
Standard Deviation 2.8
|
-0.1 Units on a scale
Standard Deviation 1.6
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 30 (n=6,9,8,8)
|
0.3 Units on a scale
Standard Deviation 3.7
|
1.2 Units on a scale
Standard Deviation 2.4
|
1.6 Units on a scale
Standard Deviation 2.4
|
0.3 Units on a scale
Standard Deviation 3.3
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 40 (n=4,9,7,8)
|
2.3 Units on a scale
Standard Deviation 2.2
|
0.8 Units on a scale
Standard Deviation 3.5
|
0.7 Units on a scale
Standard Deviation 2.0
|
0.5 Units on a scale
Standard Deviation 3.2
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 52 (n=5,8,7,7)
|
0.4 Units on a scale
Standard Deviation 4.5
|
1.0 Units on a scale
Standard Deviation 3.8
|
1.1 Units on a scale
Standard Deviation 2.1
|
0.6 Units on a scale
Standard Deviation 2.5
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 78 (n=4,8,6,7)
|
1.8 Units on a scale
Standard Deviation 2.5
|
-1.4 Units on a scale
Standard Deviation 3.9
|
-0.3 Units on a scale
Standard Deviation 1.2
|
0.0 Units on a scale
Standard Deviation 3.2
|
|
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Week 104 (n=0,1,1,0)
|
NA Units on a scale
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
-2.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-1.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
NA Units on a scale
Standard Deviation NA
Data were not analyzed as no participants were evaluable for the particular week.
|
Adverse Events
ACC-001 3 Micrograms + QS-21
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ACC-001 10 Micrograms + QS-21
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ACC-001 30 Micrograms + QS-21
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
QS-21
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACC-001 3 Micrograms + QS-21
n=6 participants at risk
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 10 Micrograms + QS-21
n=9 participants at risk
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
ACC-001 30 Micrograms + QS-21
n=9 participants at risk
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
QS-21
n=8 participants at risk
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Vomiting
|
16.7%
1/6
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.
|
11.1%
1/9
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.
|
11.1%
1/9
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%
0/8
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
Rash pruritic
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Urticaria
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/6
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%
0/9
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%
0/9
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.
|
12.5%
1/8
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
Constipation
|
16.7%
1/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Dental caries
|
0.00%
0/6
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%
0/9
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%
0/9
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.
|
12.5%
1/8
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
Gastric ulcer
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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 erythema
|
33.3%
2/6
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.
|
11.1%
1/9
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.
|
11.1%
1/9
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%
0/8
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 haematoma
|
0.00%
0/6
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%
0/9
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%
0/9
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.
|
12.5%
1/8
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 pain
|
16.7%
1/6
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%
0/9
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.
|
11.1%
1/9
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%
2/8
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 swelling
|
50.0%
3/6
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.
|
11.1%
1/9
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.
|
11.1%
1/9
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%
0/8
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
Pyrexia
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Cellulitis
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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
Enterocolitis infectious
|
0.00%
0/6
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%
0/9
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%
0/9
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.
|
12.5%
1/8
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
Folliculitis
|
0.00%
0/6
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.
|
11.1%
1/9
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.
|
11.1%
1/9
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%
0/8
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 viral
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Gingivitis
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Herpes zoster
|
0.00%
0/6
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%
0/9
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%
0/9
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.
|
12.5%
1/8
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
Influenza
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
|
33.3%
2/6
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.
|
44.4%
4/9
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%
3/9
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.
|
37.5%
3/8
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
Periodontitis
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Pharyngitis
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Chillblains
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Contusion
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Fall
|
16.7%
1/6
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.
|
22.2%
2/9
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%
0/9
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.
|
12.5%
1/8
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
Head injury
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Ligament sprain
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Spinal compression fracture
|
16.7%
1/6
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.
|
11.1%
1/9
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%
0/9
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.
|
12.5%
1/8
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
Subcutaneous haematoma
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Subdural haematoma
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Wrist fracture
|
0.00%
0/6
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%
0/9
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%
0/9
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.
|
12.5%
1/8
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%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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 cholesterol increased
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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 pressure decreased
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Electrocardiogram QT prolonged
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Positive Rombergism
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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 present
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6
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%
0/9
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.
|
11.1%
1/9
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.
|
12.5%
1/8
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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.
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
16.7%
1/6
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.
|
11.1%
1/9
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%
0/9
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.
|
12.5%
1/8
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.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6
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.
|
22.2%
2/9
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.
|
11.1%
1/9
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%
0/8
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
Cerebral infarction
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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
Cerebral microhaemorrhage
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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.
|
12.5%
1/8
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
Dizziness
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Dyskinesia
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Haemorrhagic cerebral infarction
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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
Hypoaesthesia
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Intercostal neuralgia
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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
Loss of consciousness
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Meralgia paraesthetica
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Agitation
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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
Anxiety
|
0.00%
0/6
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%
0/9
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.
|
11.1%
1/9
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%
0/8
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
Depression
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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
Dermatitis
|
0.00%
0/6
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.
|
11.1%
1/9
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%
0/9
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%
0/8
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
Haemorrhage subcutaneous
|
16.7%
1/6
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%
0/9
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%
0/9
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%
0/8
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