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Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00479557
Recruitment Status : Completed
First Posted : May 28, 2007
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer Disease
Interventions Biological: ACC-001 + QS-21
Biological: ACC-001
Biological: QS-21
Drug: Placebo: Phosphate buffered saline
Enrollment 86
Recruitment Details Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).
Pre-assignment Details The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.
Arm/Group Title ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Hide Arm/Group Description Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Period Title: Overall Study
Started 36 61 40 35 12 44 17
Treated 36 60 [1] 40 35 12 44 17
Completed 26 51 32 30 8 31 15
Not Completed 10 10 8 5 4 13 2
Reason Not Completed
Death             0             0             0             0             0             1             0
Lack of Efficacy             1             0             0             0             0             0             0
Lost to Follow-up             0             2             0             2             0             0             0
Adverse Event (AE) related to Study Drug             1             0             3             2             0             1             0
AE not related to Study Drug             1             3             0             0             2             2             1
Caregiver Request             2             2             2             0             1             2             0
Investigator Request             0             0             1             0             0             0             0
Subject Request             3             0             1             1             1             4             1
Other             2             3             1             0             0             3             0
[1]
One participant discontinued due to an AE, with an outcome of death.
Arm/Group Title ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline Total
Hide Arm/Group Description Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Total of all reporting groups
Overall Number of Baseline Participants 36 61 40 35 12 44 17 245
Hide Baseline Analysis Population Description
245 participants were randomized in both studies (86 participants in 3134K1-200-EU [B2571004] and 159 participants in 3134K1-2201-US [B2571005]) and included in the analysis below. One participant of the randomized participants did not receive treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 36 participants 61 participants 40 participants 35 participants 12 participants 44 participants 17 participants 245 participants
65.7  (7.75) 69.3  (9.57) 69.0  (9.27) 71.9  (8.96) 70.9  (9.59) 68.8  (8.07) 69.4  (7.82) 69.1  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 61 participants 40 participants 35 participants 12 participants 44 participants 17 participants 245 participants
Female
16
  44.4%
29
  47.5%
22
  55.0%
19
  54.3%
8
  66.7%
31
  70.5%
14
  82.4%
139
  56.7%
Male
20
  55.6%
32
  52.5%
18
  45.0%
16
  45.7%
4
  33.3%
13
  29.5%
3
  17.6%
106
  43.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Number of participants
 Number Analyzed 36 participants 61 participants 40 participants 35 participants 12 participants 44 participants 17 participants 245 participants
Asian 0 0 0 0 1 0 0 1
Black or African American 1 0 1 0 0 1 0 3
Other 2 1 1 1 0 0 0 5
White 33 60 38 34 11 43 17 236
Mini-Mental State Examination (MMSE) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 36 participants 61 participants 40 participants 35 participants 12 participants 44 participants 17 participants 245 participants
21.4  (2.96) 21.4  (3.38) 21.0  (2.92) 21.6  (3.16) 21.8  (3.60) 21.7  (3.11) 21.2  (3.17) 21.4  (3.13)
[1]
Measure Description: The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
MMSE Stratum   [1] 
Measure Type: Number
Unit of measure:  Number of participants
 Number Analyzed 36 participants 61 participants 40 participants 35 participants 12 participants 44 participants 17 participants 245 participants
High (21 - 26) 26 40 24 23 8 29 11 161
Low (16 - 20) 10 21 16 12 4 15 6 84
[1]
Measure Description: The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
1.Primary Outcome
Title Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants with documented use of at least one dose of study drug.
Arm/Group Title ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Hide Arm/Group Description:
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Overall Number of Participants Analyzed 36 60 40 35 12 44 17
Measure Type: Number
Unit of Measure: percentage of participants
Percentage of participants with AEs 97.2 93.3 90.0 91.4 83.3 90.9 100
Percentage of participants with SAEs 16.7 18.3 17.5 14.3 41.7 11.4 17.6
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Hide Description The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.
Arm/Group Title ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Hide Arm/Group Description:
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Overall Number of Participants Analyzed 36 60 40 35 12 44 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
Baseline (N: 36, 59, 40, 35, 12, 44, 17)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
53.1
(47.1 to 59.8)
50.0
(50.0 to 50.0)
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)
56.6
(49.1 to 65.3)
69.0
(57.4 to 83.0)
86.5
(65.7 to 113.9)
51.7
(48.3 to 55.2)
50.0
(50.0 to 50.0)
52.5
(47.5 to 58.1)
50.0
(50.0 to 50.0)
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)
53.2
(48.5 to 58.4)
77.1
(61.9 to 96.0)
82.8
(63.0 to 108.8)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
51.3
(48.7 to 53.9)
50.0
(50.0 to 50.0)
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)
634.8
(322.7 to 1248.5)
1089.4
(646.0 to 1837.2)
1343.5
(716.0 to 2521.1)
73.4
(50.6 to 106.4)
103.7
(38.2 to 281.4)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)
497.4
(253.5 to 976.1)
885.2
(530.0 to 1478.7)
1098.2
(626.9 to 1924.0)
66.3
(48.2 to 91.1)
99.8
(38.8 to 256.6)
52.4
(47.6 to 57.7)
50.0
(50.0 to 50.0)
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)
292.3
(156.5 to 546.0)
762.8
(468.5 to 1242.2)
878.5
(531.3 to 1452.6)
77.0
(48.0 to 123.3)
94.9
(39.8 to 226.5)
53.0
(47.1 to 59.7)
50.0
(50.0 to 50.0)
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)
907.5
(474.6 to 1735.6)
2892.3
(1705.9 to 4903.8)
3136.8
(1877.6 to 5240.7)
89.6
(50.8 to 158.3)
199.4
(73.7 to 539.8)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)
996.1
(487.1 to 2037.1)
3273.2
(2083.9 to 5141.4)
3324.7
(1959.4 to 5641.3)
91.7
(55.2 to 152.1)
133.9
(56.1 to 319.9)
52.6
(47.5 to 58.1)
50.0
(50.0 to 50.0)
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)
547.8
(278.8 to 1076.3)
1827.6
(1145.3 to 2916.1)
1231.3
(712.2 to 2128.6)
76.1
(52.1 to 111.1)
139.1
(52.1 to 371.3)
52.3
(47.4 to 57.4)
50.0
(50.0 to 50.0)
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)
2011.2
(986.9 to 4098.8)
4299.6
(2843.8 to 6500.8)
5407.7
(3676.0 to 7955.3)
108.9
(61.9 to 191.8)
334.1
(77.1 to 1448.3)
52.4
(47.6 to 57.6)
50.0
(50.0 to 50.0)
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)
2028.9
(1035.8 to 3973.8)
4316.8
(2900.2 to 6425.2)
4713.0
(3076.0 to 7221.2)
110.4
(64.1 to 190.0)
234.5
(65.3 to 842.5)
51.8
(48.2 to 55.7)
50.0
(50.0 to 50.0)
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)
1167.3
(609.1 to 2237.1)
2147.2
(1407.6 to 3275.3)
2292.9
(1436.6 to 3659.8)
97.2
(62.4 to 151.3)
211.0
(53.6 to 830.7)
52.1
(47.9 to 56.7)
50.0
(50.0 to 50.0)
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)
937.3
(482.0 to 1822.6)
1364.4
(911.9 to 2041.4)
1262.3
(828.5 to 1923.2)
80.7
(54.8 to 118.9)
168.4
(52.4 to 541.3)
52.8
(47.3 to 58.8)
50.0
(50.0 to 50.0)
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)
2031.6
(1024.2 to 4029.7)
5744.6
(3609.1 to 9143.7)
6677.3
(3678.7 to 12120.1)
160.6
(69.7 to 370.2)
491.6
(85.9 to 2812.2)
55.0
(45.2 to 66.9)
50.0
(50.0 to 50.0)
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)
2635.7
(1355.5 to 5125.2)
5906.1
(4058.8 to 8594.2)
7642.5
(5057.9 to 11547.9)
159.2
(74.2 to 341.8)
463.7
(81.1 to 2650.5)
53.4
(46.7 to 60.9)
50.0
(50.0 to 50.0)
Week 66 (N: 31, 54,34, 31, 9, 33, 15)
1372.0
(717.1 to 2625.1)
2867.4
(1835.9 to 4478.5)
2882.2
(1793.1 to 4632.8)
166.3
(78.8 to 350.9)
280.0
(56.3 to 1393.9)
63.5
(43.7 to 92.3)
50.0
(50.0 to 50.0)
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)
1108.4
(585.1 to 2099.4)
1867.5
(1197.4 to 2912.5)
1338.1
(827.3 to 2164.4)
142.7
(71.5 to 285.1)
256.1
(58.2 to 1128.2)
53.6
(46.5 to 61.6)
50.0
(50.0 to 50.0)
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)
1824.6
(1063.2 to 3131.2)
2497.0
(644.8 to 9670.1)
543.0
(33.6 to 8767.8)
76.8
(27.8 to 211.9)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)
1326.1
(785.0 to 2240.2)
2212.7
(406.4 to 12048.4)
243.3
(28.8 to 2052.4)
98.9
(30.7 to 318.3)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
3.Secondary Outcome
Title GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Hide Description The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
Time Frame Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.
Arm/Group Title ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Hide Arm/Group Description:
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Overall Number of Participants Analyzed 36 60 40 35 12 44 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
Baseline (N: 36, 59, 40, 35, 12, 44, 17)
32.3
(24.6 to 42.4)
38.2
(30.8 to 47.2)
34.2
(27.7 to 42.2)
32.9
(28.1 to 38.5)
40.3
(27.1 to 59.9)
30.8
(26.4 to 36.0)
25.0
(25.0 to 25.0)
Week 2 (N: 35, 60, 39, 35, 12,43, 16)
85.1
(54.2 to 133.8)
127.7
(79.5 to 205.0)
254.5
(133.6 to 484.9)
46.5
(32.4 to 66.7)
76.9
(40.5 to 146.2)
31.5
(26.6 to 37.3)
26.5
(23.4 to 29.9)
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)
82.3
(52.8 to 128.4)
123.4
(75.9 to 200.7)
276.6
(143.3 to 533.6)
48.2
(33.2 to 70.2)
92.0
(46.7 to 181.1)
33.2
(28.0 to 39.3)
27.3
(24.0 to 30.9)
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)
626.5
(340.5 to 1152.8)
1283.8
(742.6 to 2219.4)
1736.6
(906.4 to 3327.1)
72.3
(40.8 to 128.2)
144.1
(55.9 to 371.6)
31.1
(26.6 to 36.3)
25.0
(25.0 to 25.0)
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)
758.9
(388.6 to 1482.4)
1903.8
(1097.7 to 3301.9)
2769.5
(1407.2 to 5450.9)
70.8
(40.8 to 123.0)
166.4
(60.3 to 459.3)
31.0
(26.1 to 36.8)
26.3
(23.6 to 29.4)
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)
595.2
(310.0 to 1143.0)
1697.7
(980.8 to 2938.6)
2598.1
(1382.6 to 4882.0)
69.9
(38.3 to 127.6)
157.1
(56.1 to 440.1)
36.6
(28.0 to 47.9)
27.3
(24.0 to 31.1)
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)
770.2
(416.1 to 1425.6)
2721.0
(1608.3 to 4603.4)
5271.3
(2904.4 to 9567.3)
80.8
(40.2 to 162.3)
290.7
(71.8 to 1177.7)
31.0
(25.5 to 37.8)
25.0
(25.0 to 25.0)
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)
727.3
(395.0 to 1339.0)
3098.3
(1904.1 to 5041.2)
5666.4
(3264.6 to 9835.3)
93.4
(47.5 to 183.4)
271.8
(70.5 to 1047.5)
34.5
(27.6 to 43.0)
25.0
(25.0 to 25.0)
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)
461.3
(260.4 to 817.2)
1862.5
(1137.9 to 3048.3)
2672.4
(1553.6 to 4597.0)
90.8
(48.1 to 171.3)
296.2
(56.3 to 1549.6)
30.9
(26.1 to 36.7)
26.6
(23.3 to 30.2)
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)
669.0
(388.0 to 1153.6)
1915.3
(1256.2 to 2920.0)
3593.2
(2050.4 to 6296.9)
105.5
(50.2 to 221.6)
590.9
(63.4 to 5511.6)
31.3
(26.1 to 37.5)
25.0
(25.0 to 25.0)
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)
717.3
(432.6 to 1189.5)
2259.4
(1524.0 to 3349.6)
4147.2
(2423.1 to 7098.1)
128.4
(63.1 to 261.1)
343.3
(49.9 to 2361.4)
37.8
(27.7 to 51.6)
25.0
(25.0 to 25.0)
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)
559.0
(350.7 to 891.0)
1351.6
(885.3 to 2063.3)
1855.9
(1074.3 to 3206.1)
103.9
(54.2 to 199.3)
311.9
(39.1 to 2491.7)
34.2
(28.1 to 41.6)
25.0
(25.0 to 25.0)
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)
351.3
(210.2 to 587.2)
1049.6
(701.4 to 1570.8)
1246.4
(707.2 to 2196.7)
84.7
(45.6 to 157.3)
294.6
(41.2 to 2104.6)
32.2
(27.1 to 38.3)
25.0
(25.0 to 25.0)
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)
477.7
(305.2 to 747.7)
1529.1
(1045.4 to 2236.7)
2479.5
(1373.5 to 4476.4)
121.1
(52.1 to 281.7)
436.9
(52.1 to 3662.2)
36.2
(28.4 to 46.3)
27.2
(22.7 to 32.5)
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)
598.7
(375.1 to 955.5)
1696.1
(1173.6 to 2451.3)
2681.8
(1480.7 to 4857.0)
109.8
(49.4 to 244.1)
438.5
(51.5 to 3734.3)
34.3
(27.2 to 43.2)
29.5
(22.6 to 38.6)
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)
457.6
(282.2 to 742.1)
1422.0
(980.7 to 2061.9)
1637.2
(961.9 to 2786.6)
114.3
(51.6 to 253.1)
342.1
(41.2 to 2839.9)
36.1
(26.5 to 49.1)
27.8
(23.8 to 32.6)
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)
368.2
(238.4 to 568.7)
1204.4
(815.6 to 1778.6)
1217.7
(706.1 to 2100.1)
107.5
(52.2 to 221.4)
346.0
(31.2 to 3832.0)
34.6
(27.9 to 43.0)
28.9
(23.4 to 35.8)
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)
391.2
(205.6 to 744.2)
1203.4
(399.9 to 3621.9)
679.2
(28.5 to 16208.4)
98.9
(18.4 to 530.4)
25.0
(25.0 to 25.0)
28.3
(20.5 to 39.1)
25.0
(25.0 to 25.0)
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)
299.1
(144.2 to 620.8)
1561.8
(438.0 to 5569.0)
620.3
(78.8 to 4882.2)
176.7
(26.1 to 1197.0)
25.0
(25.0 to 25.0)
25.0
(25.0 to 25.0)
25.0
(25.0 to 25.0)
4.Secondary Outcome
Title Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
Hide Description IgG subtypes were not assessed
Time Frame Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACC 3 μg+QS-21 ACC 10 μg+QS-21 ACC 30 μg+QS-21 ACC 10 μg ACC 30 μg QS-21 Alone Phosphate Buffered Saline
Hide Arm/Group Description:
Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Hide Arm/Group Description Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
All-Cause Mortality
ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/36 (16.67%)   11/60 (18.33%)   7/40 (17.50%)   5/35 (14.29%)   5/12 (41.67%)   5/44 (11.36%)   3/17 (17.65%) 
Cardiac disorders               
Myocardial infarction * 1  1/36 (2.78%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Atrial fibrillation * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Cardiac arrest * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Cyanosis * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Ear and labyrinth disorders               
Vertigo positional * 1  0/36 (0.00%)  2/60 (3.33%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders               
Gastrointestinal haemorrhage * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Intestinal obstruction * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
General disorders               
Fatigue * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Feeling cold * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Gait disturbance * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Malaise * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Oedema peripheral * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Hepatobiliary disorders               
Bile duct stone * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Cholelithiasis * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Infections and infestations               
Gastroenteritis * 1  1/36 (2.78%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Urinary tract infection * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications               
Clavicle fracture * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Humerus fracture * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Metabolism and nutrition disorders               
Dehydration * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Decreased appetite * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Intervertebral disc protrusion * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Carcinoid tumour pulmonary * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Lung cancer metastatic * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Lung neoplasm malignant * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Non-Hodgkins lymphoma * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Prostate cancer * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Squamous cell carcinoma * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Uterine cancer * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Nervous system disorders               
Dizziness * 1  1/36 (2.78%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Syncope * 1  1/36 (2.78%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Vasogenic cerebral oedema * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Ataxia * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Balance disorder * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Bradykinesia * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Cerebrovascular accident * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Convulsion * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Dementia Alzheimers type * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Dystonia * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Embolic stroke * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Headache * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Transient ischaemic attack * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Psychiatric disorders               
Agitation * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Confusional state * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Delusion * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Hallucination * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Restlessness * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Renal and urinary disorders               
Renal failure acute * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Stress urinary incontinence * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders               
Skin erosion * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Vascular disorders               
Deep vein thrombosis * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Hypotension * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Orthostatic hypotension * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Vasculitis * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACC 3 µg+QS-21 ACC 10 µg+QS-21 ACC 30 µg+QS-21 ACC 10 µg ACC 30 µg QS-21 Alone Phosphate Buffered Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/36 (94.44%)   48/60 (80.00%)   35/40 (87.50%)   28/35 (80.00%)   10/12 (83.33%)   40/44 (90.91%)   17/17 (100.00%) 
Blood and lymphatic system disorders               
Anaemia * 1  1/36 (2.78%)  1/60 (1.67%)  1/40 (2.50%)  1/35 (2.86%)  0/12 (0.00%)  2/44 (4.55%)  1/17 (5.88%) 
Iron deficiency anaemia * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Eye disorders               
Cataract * 1  0/36 (0.00%)  3/60 (5.00%)  1/40 (2.50%)  1/35 (2.86%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Eye movement disorder * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders               
Diarrhoea * 1  10/36 (27.78%)  6/60 (10.00%)  4/40 (10.00%)  4/35 (11.43%)  2/12 (16.67%)  3/44 (6.82%)  1/17 (5.88%) 
Nausea * 1  5/36 (13.89%)  9/60 (15.00%)  1/40 (2.50%)  2/35 (5.71%)  0/12 (0.00%)  5/44 (11.36%)  1/17 (5.88%) 
Vomiting * 1  5/36 (13.89%)  4/60 (6.67%)  1/40 (2.50%)  0/35 (0.00%)  2/12 (16.67%)  5/44 (11.36%)  0/17 (0.00%) 
Abdominal pain * 1  0/36 (0.00%)  4/60 (6.67%)  0/40 (0.00%)  2/35 (5.71%)  1/12 (8.33%)  2/44 (4.55%)  0/17 (0.00%) 
Constipation * 1  0/36 (0.00%)  2/60 (3.33%)  1/40 (2.50%)  0/35 (0.00%)  2/12 (16.67%)  1/44 (2.27%)  0/17 (0.00%) 
Gastrooesophageal reflux disease * 1  0/36 (0.00%)  1/60 (1.67%)  2/40 (5.00%)  0/35 (0.00%)  2/12 (16.67%)  0/44 (0.00%)  0/17 (0.00%) 
Haemorrhoids * 1  1/36 (2.78%)  1/60 (1.67%)  1/40 (2.50%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Functional gastrointestinal disorder * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
General disorders               
Injection site pain * 1  7/36 (19.44%)  17/60 (28.33%)  9/40 (22.50%)  4/35 (11.43%)  1/12 (8.33%)  6/44 (13.64%)  0/17 (0.00%) 
Fatigue * 1  5/36 (13.89%)  7/60 (11.67%)  4/40 (10.00%)  1/35 (2.86%)  0/12 (0.00%)  5/44 (11.36%)  1/17 (5.88%) 
Injection site erythema * 1  7/36 (19.44%)  9/60 (15.00%)  6/40 (15.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Injection site swelling * 1  2/36 (5.56%)  6/60 (10.00%)  7/40 (17.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Asthenia * 1  1/36 (2.78%)  2/60 (3.33%)  1/40 (2.50%)  3/35 (8.57%)  2/12 (16.67%)  1/44 (2.27%)  0/17 (0.00%) 
Oedema peripheral * 1  2/36 (5.56%)  2/60 (3.33%)  2/40 (5.00%)  1/35 (2.86%)  1/12 (8.33%)  2/44 (4.55%)  0/17 (0.00%) 
Injection site pruritus * 1  1/36 (2.78%)  3/60 (5.00%)  3/40 (7.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Gait disturbance * 1  1/36 (2.78%)  3/60 (5.00%)  0/40 (0.00%)  2/35 (5.71%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Injection site induration * 1  0/36 (0.00%)  4/60 (6.67%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Malaise * 1  2/36 (5.56%)  1/60 (1.67%)  1/40 (2.50%)  0/35 (0.00%)  2/12 (16.67%)  0/44 (0.00%)  0/17 (0.00%) 
Injection site bruising * 1  1/36 (2.78%)  0/60 (0.00%)  2/40 (5.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Injection site reaction * 1  3/36 (8.33%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Injection site warmth * 1  1/36 (2.78%)  3/60 (5.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Pyrexia * 1  0/36 (0.00%)  3/60 (5.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Injection site inflammation * 1  0/36 (0.00%)  0/60 (0.00%)  2/40 (5.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Irritability * 1  2/36 (5.56%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Injection site haemorrhage * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Infections and infestations               
Urinary tract infection * 1  3/36 (8.33%)  6/60 (10.00%)  2/40 (5.00%)  4/35 (11.43%)  0/12 (0.00%)  2/44 (4.55%)  4/17 (23.53%) 
Nasopharyngitis * 1  4/36 (11.11%)  6/60 (10.00%)  1/40 (2.50%)  2/35 (5.71%)  0/12 (0.00%)  4/44 (9.09%)  1/17 (5.88%) 
Upper respiratory tract infection * 1  3/36 (8.33%)  3/60 (5.00%)  5/40 (12.50%)  3/35 (8.57%)  1/12 (8.33%)  1/44 (2.27%)  1/17 (5.88%) 
Sinusitis * 1  0/36 (0.00%)  2/60 (3.33%)  1/40 (2.50%)  0/35 (0.00%)  1/12 (8.33%)  1/44 (2.27%)  1/17 (5.88%) 
Bronchitis * 1  3/36 (8.33%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Viral upper respiratory tract infection * 1  1/36 (2.78%)  2/60 (3.33%)  0/40 (0.00%)  1/35 (2.86%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Influenza * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  4/44 (9.09%)  0/17 (0.00%) 
Oral herpes * 1  0/36 (0.00%)  2/60 (3.33%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Rhinitis * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  2/44 (4.55%)  0/17 (0.00%) 
Lower respiratory tract infection * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  2/35 (5.71%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Tooth infection * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Fungal skin infection * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  1/17 (5.88%) 
Furuncle * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Gingivitis * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  1/44 (2.27%)  0/17 (0.00%) 
Herpes simplex ophthalmic * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications               
Fall * 1  3/36 (8.33%)  3/60 (5.00%)  3/40 (7.50%)  4/35 (11.43%)  1/12 (8.33%)  9/44 (20.45%)  0/17 (0.00%) 
Contusion * 1  1/36 (2.78%)  1/60 (1.67%)  3/40 (7.50%)  1/35 (2.86%)  0/12 (0.00%)  3/44 (6.82%)  1/17 (5.88%) 
Laceration * 1  1/36 (2.78%)  3/60 (5.00%)  1/40 (2.50%)  0/35 (0.00%)  1/12 (8.33%)  1/44 (2.27%)  0/17 (0.00%) 
Arthropod bite * 1  2/36 (5.56%)  2/60 (3.33%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  1/17 (5.88%) 
Procedural pain * 1  2/36 (5.56%)  0/60 (0.00%)  2/40 (5.00%)  1/35 (2.86%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Excoriation * 1  0/36 (0.00%)  3/60 (5.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Wound * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  1/12 (8.33%)  1/44 (2.27%)  0/17 (0.00%) 
Thermal burn * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Skin injury * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Spinal compression fracture * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Tooth fracture * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Investigations               
Weight decreased * 1  1/36 (2.78%)  4/60 (6.67%)  2/40 (5.00%)  0/35 (0.00%)  2/12 (16.67%)  1/44 (2.27%)  1/17 (5.88%) 
Weight increased * 1  1/36 (2.78%)  1/60 (1.67%)  1/40 (2.50%)  2/35 (5.71%)  0/12 (0.00%)  2/44 (4.55%)  1/17 (5.88%) 
Blood creatine phosphokinase increased * 1  3/36 (8.33%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Blood urea increased * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Blood albumin decreased * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Blood creatinine increased * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Haematocrit decreased * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Haemoglobin decreased * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  2/12 (16.67%)  0/44 (0.00%)  0/17 (0.00%) 
Hyponatraemia * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain * 1  2/36 (5.56%)  5/60 (8.33%)  3/40 (7.50%)  4/35 (11.43%)  0/12 (0.00%)  4/44 (9.09%)  3/17 (17.65%) 
Arthralgia * 1  2/36 (5.56%)  5/60 (8.33%)  4/40 (10.00%)  1/35 (2.86%)  0/12 (0.00%)  2/44 (4.55%)  2/17 (11.76%) 
Musculoskeletal pain * 1  1/36 (2.78%)  3/60 (5.00%)  2/40 (5.00%)  2/35 (5.71%)  0/12 (0.00%)  4/44 (9.09%)  0/17 (0.00%) 
Pain in extremity * 1  4/36 (11.11%)  3/60 (5.00%)  1/40 (2.50%)  2/35 (5.71%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Osteoarthritis * 1  1/36 (2.78%)  2/60 (3.33%)  4/40 (10.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Muscle spasms * 1  1/36 (2.78%)  1/60 (1.67%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  1/17 (5.88%) 
Osteoporosis * 1  1/36 (2.78%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  1/12 (8.33%)  1/44 (2.27%)  0/17 (0.00%) 
Bursitis * 1  1/36 (2.78%)  0/60 (0.00%)  2/40 (5.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Arthritis * 1  0/36 (0.00%)  0/60 (0.00%)  2/40 (5.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Torticollis * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Squamous cell carcinoma * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  3/35 (8.57%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Basal cell carcinoma * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  1/35 (2.86%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Nervous system disorders               
Headache * 1  3/36 (8.33%)  14/60 (23.33%)  4/40 (10.00%)  2/35 (5.71%)  0/12 (0.00%)  8/44 (18.18%)  1/17 (5.88%) 
Dizziness * 1  3/36 (8.33%)  7/60 (11.67%)  4/40 (10.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Cognitive disorder * 1  1/36 (2.78%)  3/60 (5.00%)  1/40 (2.50%)  1/35 (2.86%)  0/12 (0.00%)  1/44 (2.27%)  1/17 (5.88%) 
Somnolence * 1  1/36 (2.78%)  2/60 (3.33%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  1/44 (2.27%)  1/17 (5.88%) 
Syncope * 1  0/36 (0.00%)  2/60 (3.33%)  3/40 (7.50%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Aphasia * 1  2/36 (5.56%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Dementia Alzheimers type * 1  1/36 (2.78%)  0/60 (0.00%)  1/40 (2.50%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Apraxia * 1  2/36 (5.56%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Cerebral microhaemorrhage * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  1/17 (5.88%) 
Lethargy * 1  3/36 (8.33%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Presyncope * 1  1/36 (2.78%)  0/60 (0.00%)  2/40 (5.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Clonus * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Extrapyramidal disorder * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/35 (2.86%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Sciatica * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  2/35 (5.71%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Amnesia * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Memory impairment * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Mental impairment * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Migraine * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Speech disorder * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Unresponsive to stimuli * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Psychiatric disorders               
Depression * 1  5/36 (13.89%)  4/60 (6.67%)  4/40 (10.00%)  8/35 (22.86%)  3/12 (25.00%)  5/44 (11.36%)  1/17 (5.88%) 
Agitation * 1  4/36 (11.11%)  4/60 (6.67%)  0/40 (0.00%)  5/35 (14.29%)  2/12 (16.67%)  4/44 (9.09%)  2/17 (11.76%) 
Anxiety * 1  3/36 (8.33%)  5/60 (8.33%)  1/40 (2.50%)  2/35 (5.71%)  2/12 (16.67%)  2/44 (4.55%)  0/17 (0.00%) 
Confusional state * 1  2/36 (5.56%)  1/60 (1.67%)  0/40 (0.00%)  2/35 (5.71%)  0/12 (0.00%)  2/44 (4.55%)  0/17 (0.00%) 
Abnormal dreams * 1  3/36 (8.33%)  0/60 (0.00%)  1/40 (2.50%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Aggression * 1  1/36 (2.78%)  1/60 (1.67%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  2/17 (11.76%) 
Delusion * 1  1/36 (2.78%)  1/60 (1.67%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  2/17 (11.76%) 
Hallucination * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  2/44 (4.55%)  1/17 (5.88%) 
Hallucination, visual * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  2/35 (5.71%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Paranoia * 1  2/36 (5.56%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Delirium * 1  1/36 (2.78%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Depressive symptom * 1  0/36 (0.00%)  0/60 (0.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  2/17 (11.76%) 
Disorientation * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Hallucination, auditory * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Renal and urinary disorders               
Urinary incontinence * 1  2/36 (5.56%)  1/60 (1.67%)  3/40 (7.50%)  2/35 (5.71%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Incontinence * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  1/17 (5.88%) 
Hydronephrosis * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Renal failure * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Reproductive system and breast disorders               
Breast swelling * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders               
Cough * 1  6/36 (16.67%)  4/60 (6.67%)  2/40 (5.00%)  2/35 (5.71%)  2/12 (16.67%)  4/44 (9.09%)  2/17 (11.76%) 
Oropharyngeal pain * 1  1/36 (2.78%)  3/60 (5.00%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Rhinorrhoea * 1  2/36 (5.56%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/36 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Pleural effusion * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders               
Rash * 1  3/36 (8.33%)  1/60 (1.67%)  1/40 (2.50%)  2/35 (5.71%)  0/12 (0.00%)  1/44 (2.27%)  0/17 (0.00%) 
Skin lesion * 1  4/36 (11.11%)  3/60 (5.00%)  0/40 (0.00%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
Hyperhidrosis * 1  1/36 (2.78%)  0/60 (0.00%)  1/40 (2.50%)  1/35 (2.86%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Ecchymosis * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  1/17 (5.88%) 
Petechiae * 1  1/36 (2.78%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Intertrigo * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Rash pruritic * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  1/12 (8.33%)  0/44 (0.00%)  0/17 (0.00%) 
Urticaria * 1  0/36 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  1/17 (5.88%) 
Vascular disorders               
Hypertension * 1  4/36 (11.11%)  3/60 (5.00%)  1/40 (2.50%)  3/35 (8.57%)  1/12 (8.33%)  5/44 (11.36%)  1/17 (5.88%) 
Haematoma * 1  0/36 (0.00%)  1/60 (1.67%)  1/40 (2.50%)  0/35 (0.00%)  0/12 (0.00%)  4/44 (9.09%)  1/17 (5.88%) 
Orthostatic hypotension * 1  0/36 (0.00%)  0/60 (0.00%)  2/40 (5.00%)  0/35 (0.00%)  0/12 (0.00%)  0/44 (0.00%)  0/17 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00479557    
Other Study ID Numbers: 3134K1-200
B2571004 ( Other Identifier: Alias Study Number )
2006-002061-39 ( EudraCT Number )
First Submitted: May 24, 2007
First Posted: May 28, 2007
Results First Submitted: May 6, 2014
Results First Posted: January 1, 2016
Last Update Posted: January 1, 2016