Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00479557
Collaborator
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC (Other)
86
24
4
68.1
3.6
0.1
Study Details
Study Description
Brief Summary
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
Jan 1, 2013
Actual Study Completion Date
:
Jan 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 arm 1: ACC-001 (Vanutide Cridificar)+ QS-21 |
Biological: ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
|
| Active Comparator: 2 arm 2: ACC-001 |
Biological: ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
|
| Placebo Comparator: 3 arm 3: QS-21 |
Biological: QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
|
| Placebo Comparator: 4 Drug: Phosphate Buffered Saline (PBS) |
Drug: Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) [approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.]
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.
Secondary Outcome Measures
- 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 [Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104]
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.
- 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 [Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104]
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
- 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) [Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104]
IgG subtypes were not assessed
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
-
Brain MRI consistent with Alzheimer Disease
-
Concurent use of Chloniesterase inhibitor or memantine allowed if stable
-
Other inclusion criteria apply
Exclusion Criteria:
-
Significant Neurological Disease other than Alzheimer's disease
-
Major psychiatric disorder
-
Contraindication to undergo brain MRI
-
Clinically significant systemic illness
-
Other exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Pitie-Salpetriere | Paris | Cedex 13 (MRI) | France | 75651 |
| 2 | Hôpital Pitié-Salpétrière | Paris Cedex 13 | Paris | France | 75651 |
| 3 | Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources | Bordeaux | France | 33076 | |
| 4 | CHRU de Lille | Lille (MRI) | France | 59037 | |
| 5 | CHRU de Lille | Lille | France | 59037 | |
| 6 | Hôpital Sainte-Marguerite | MARSEILLE cedex 5 | France | 13385 | |
| 7 | CHU Hôpital Gui de Chaulliac | Montpellier | France | 34295 | |
| 8 | Groupe Hospitalier Broca-La Rochefoucauld | Paris | France | 75013 | |
| 9 | Clinique de L'Union | St JEAN | France | 31240 | |
| 10 | Hôpital LA GRAVE | TOULOUSE Cedex 9 | France | 31059 | |
| 11 | Chru Purpan | Toulouse | France | 31300 | |
| 12 | Clinique PASTEUR | Toulouse | France | 31300 | |
| 13 | Unversitätsklinikum Freiburg | Freiburg | Baden- Württemberg | Germany | 79106 |
| 14 | Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin | Berlin | Germany | 14050 | |
| 15 | Zentralinstitut fuer Seelische Gesundheit | Frankenthal | Germany | 67227 | |
| 16 | Klinik fuer Psychiatrie und Psychotherapie | Goettingen | Germany | 37075 | |
| 17 | Zentralinstitut fuer Seelische Gesundheit | Mannheim | Germany | 68159 | |
| 18 | Universitaetsklinikum Muenster | Muenster | Germany | 48149 | |
| 19 | Universitaetsklinikum Muenster | Muenster | Germany | 48165 | |
| 20 | Technische Universitaet Muenchen, Klinikum rechts der Isar | München | Germany | 81675 | |
| 21 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 22 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
| 23 | Hospital Clinico y Provincial | Barcelona | Spain | 08036 | |
| 24 | Hospital Universitario Clinico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Pfizer
- Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479557
Other Study ID Numbers:
- 3134K1-200
- B2571004
- 2006-002061-39
First Posted:
May 28, 2007
Last Update Posted:
Jan 1, 2016
Last Verified:
Nov 1, 2015
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|---|---|---|---|---|---|
| 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 | 40 | 35 | 12 | 44 | 17 |
| COMPLETED | 26 | 51 | 32 | 30 | 8 | 31 | 15 |
| NOT COMPLETED | 10 | 10 | 8 | 5 | 4 | 13 | 2 |
Baseline Characteristics
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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 Participants | 36 | 61 | 40 | 35 | 12 | 44 | 17 | 245 |
| Age (year) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [year] |
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 (Count of Participants) | ||||||||
| Female |
16
44.4%
|
29
47.5%
|
22
55%
|
19
54.3%
|
8
66.7%
|
31
70.5%
|
14
82.4%
|
139
56.7%
|
| Male |
20
55.6%
|
32
52.5%
|
18
45%
|
16
45.7%
|
4
33.3%
|
13
29.5%
|
3
17.6%
|
106
43.3%
|
| Race/Ethnicity, Customized (number of participants) [Number] | ||||||||
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
1
0.4%
|
| Black or African American |
1
2.8%
|
0
0%
|
1
2.5%
|
0
0%
|
0
0%
|
1
2.3%
|
0
0%
|
3
1.2%
|
| Other |
2
5.6%
|
1
1.6%
|
1
2.5%
|
1
2.9%
|
0
0%
|
0
0%
|
0
0%
|
5
2%
|
| White |
33
91.7%
|
60
98.4%
|
38
95%
|
34
97.1%
|
11
91.7%
|
43
97.7%
|
17
100%
|
236
96.3%
|
| Mini-Mental State Examination (MMSE) Score (score) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [score] |
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)
|
| MMSE Stratum (number of participants) [Number] | ||||||||
| High (21 - 26) |
26
72.2%
|
40
65.6%
|
24
60%
|
23
65.7%
|
8
66.7%
|
29
65.9%
|
11
64.7%
|
161
65.7%
|
| Low (16 - 20) |
10
27.8%
|
21
34.4%
|
16
40%
|
12
34.3%
|
4
33.3%
|
15
34.1%
|
6
35.3%
|
84
34.3%
|
Outcome Measures
| Title | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) |
|---|---|
| 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. |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 36 | 60 | 40 | 35 | 12 | 44 | 17 |
| Percentage of participants with AEs |
97.2
270%
|
93.3
153%
|
90.0
225%
|
91.4
261.1%
|
83.3
694.2%
|
90.9
206.6%
|
100
588.2%
|
| Percentage of participants with SAEs |
16.7
46.4%
|
18.3
30%
|
17.5
43.8%
|
14.3
40.9%
|
41.7
347.5%
|
11.4
25.9%
|
17.6
103.5%
|
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 36 | 60 | 40 | 35 | 12 | 44 | 17 |
| Baseline (N: 36, 59, 40, 35, 12, 44, 17) |
50.0
|
50.0
|
50.0
|
50.0
|
50.0
|
53.1
|
50.0
|
| Week 2 (N: 35, 60, 39, 35, 12, 43, 16) |
56.6
|
69.0
|
86.5
|
51.7
|
50.0
|
52.5
|
50.0
|
| Week 4 (N: 35, 57, 38, 31, 12, 43, 16) |
53.2
|
77.1
|
82.8
|
50.0
|
50.0
|
51.3
|
50.0
|
| Week 6 (N: 36, 58, 37, 33, 12, 41, 16) |
634.8
|
1089.4
|
1343.5
|
73.4
|
103.7
|
50.0
|
50.0
|
| Week 8 (N: 33, 57, 39, 33, 12, 41, 17) |
497.4
|
885.2
|
1098.2
|
66.3
|
99.8
|
52.4
|
50.0
|
| Week 10 (N: 34, 59, 40, 33, 12, 43, 17) |
292.3
|
762.8
|
878.5
|
77.0
|
94.9
|
53.0
|
50.0
|
| Week 14 (N: 33, 52, 39, 31, 11, 33, 14) |
907.5
|
2892.3
|
3136.8
|
89.6
|
199.4
|
50.0
|
50.0
|
| Week 16 (N: 33, 59, 38, 34, 12, 41, 16) |
996.1
|
3273.2
|
3324.7
|
91.7
|
133.9
|
52.6
|
50.0
|
| Week 24 (N: 34, 58, 37, 33, 10, 40, 16) |
547.8
|
1827.6
|
1231.3
|
76.1
|
139.1
|
52.3
|
50.0
|
| Week 28 (N: 31, 51, 33, 29, 8, 36, 16) |
2011.2
|
4299.6
|
5407.7
|
108.9
|
334.1
|
52.4
|
50.0
|
| Week 30 (N: 33, 56, 36, 32, 10, 38, 16) |
2028.9
|
4316.8
|
4713.0
|
110.4
|
234.5
|
51.8
|
50.0
|
| Week 40 (N: 32, 54, 33, 33, 9, 37, 15) |
1167.3
|
2147.2
|
2292.9
|
97.2
|
211.0
|
52.1
|
50.0
|
| Week 50 (N: 29, 53, 33, 33, 9, 36, 16) |
937.3
|
1364.4
|
1262.3
|
80.7
|
168.4
|
52.8
|
50.0
|
| Week 54 (N: 27, 51, 30, 29, 9, 29, 14) |
2031.6
|
5744.6
|
6677.3
|
160.6
|
491.6
|
55.0
|
50.0
|
| Week 56 (N: 31, 52, 34, 32, 9, 34, 15) |
2635.7
|
5906.1
|
7642.5
|
159.2
|
463.7
|
53.4
|
50.0
|
| Week 66 (N: 31, 54,34, 31, 9, 33, 15) |
1372.0
|
2867.4
|
2882.2
|
166.3
|
280.0
|
63.5
|
50.0
|
| Week 78 (N: 31, 52, 32, 32, 8, 32, 14) |
1108.4
|
1867.5
|
1338.1
|
142.7
|
256.1
|
53.6
|
50.0
|
| Week 91 (N: 15, 9, 3, 8, 2, 6, 2) |
1824.6
|
2497.0
|
543.0
|
76.8
|
50.0
|
50.0
|
50.0
|
| Week 104 (N: 15, 9, 4, 7, 1, 6, 2) |
1326.1
|
2212.7
|
243.3
|
98.9
|
50.0
|
50.0
|
50.0
|
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 36 | 60 | 40 | 35 | 12 | 44 | 17 |
| Baseline (N: 36, 59, 40, 35, 12, 44, 17) |
32.3
|
38.2
|
34.2
|
32.9
|
40.3
|
30.8
|
25.0
|
| Week 2 (N: 35, 60, 39, 35, 12,43, 16) |
85.1
|
127.7
|
254.5
|
46.5
|
76.9
|
31.5
|
26.5
|
| Week 4 (N: 35, 57, 38, 31, 12, 43, 16) |
82.3
|
123.4
|
276.6
|
48.2
|
92.0
|
33.2
|
27.3
|
| Week 6 (M: 36, 58, 37, 33, 12, 41, 16) |
626.5
|
1283.8
|
1736.6
|
72.3
|
144.1
|
31.1
|
25.0
|
| Week 8 (N: 33, 57, 39, 33, 12, 41, 17) |
758.9
|
1903.8
|
2769.5
|
70.8
|
166.4
|
31.0
|
26.3
|
| Week 10 (N: 34, 59, 40, 33, 12, 43, 17) |
595.2
|
1697.7
|
2598.1
|
69.9
|
157.1
|
36.6
|
27.3
|
| Week 14 (N: 33, 52, 39, 31, 11, 33, 14) |
770.2
|
2721.0
|
5271.3
|
80.8
|
290.7
|
31.0
|
25.0
|
| Week 16 (N: 33, 59, 38, 34, 12, 41, 16) |
727.3
|
3098.3
|
5666.4
|
93.4
|
271.8
|
34.5
|
25.0
|
| Week 24 (N: 34, 58, 37, 33, 10, 40, 16) |
461.3
|
1862.5
|
2672.4
|
90.8
|
296.2
|
30.9
|
26.6
|
| Week 28 (N: 31, 51, 33, 29, 8, 36, 16) |
669.0
|
1915.3
|
3593.2
|
105.5
|
590.9
|
31.3
|
25.0
|
| Week 30 (N: 33, 56, 36, 32, 10, 38, 16) |
717.3
|
2259.4
|
4147.2
|
128.4
|
343.3
|
37.8
|
25.0
|
| Week 40 (N: 32, 54, 33, 33, 9, 37, 15) |
559.0
|
1351.6
|
1855.9
|
103.9
|
311.9
|
34.2
|
25.0
|
| Week 50 (N: 29, 53, 33, 33, 9, 36, 16) |
351.3
|
1049.6
|
1246.4
|
84.7
|
294.6
|
32.2
|
25.0
|
| Week 54 (N: 27, 51, 30, 29, 9, 29, 14) |
477.7
|
1529.1
|
2479.5
|
121.1
|
436.9
|
36.2
|
27.2
|
| Week 56 (N: 31, 52, 34, 32, 9, 34, 15) |
598.7
|
1696.1
|
2681.8
|
109.8
|
438.5
|
34.3
|
29.5
|
| Week 66 (N: 31, 54, 34, 31, 9, 33, 15) |
457.6
|
1422.0
|
1637.2
|
114.3
|
342.1
|
36.1
|
27.8
|
| Week 78 (N: 31, 52, 32, 32, 8, 32, 14) |
368.2
|
1204.4
|
1217.7
|
107.5
|
346.0
|
34.6
|
28.9
|
| Week 91 (N: 15, 9, 3, 8, 2, 6, 2) |
391.2
|
1203.4
|
679.2
|
98.9
|
25.0
|
28.3
|
25.0
|
| Week 104 (N: 15, 9, 4, 7, 1, 6, 2) |
299.1
|
1561.8
|
620.3
|
176.7
|
25.0
|
25.0
|
25.0
|
| 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) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse Events
| 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 | |||||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/36 (16.7%) | 11/60 (18.3%) | 7/40 (17.5%) | 5/35 (14.3%) | 5/12 (41.7%) | 5/44 (11.4%) | 3/17 (17.6%) | |||||||
| Cardiac disorders | ||||||||||||||
| Myocardial infarction | 1/36 (2.8%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Atrial fibrillation | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Cardiac arrest | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Cyanosis | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Vertigo positional | 0/36 (0%) | 2/60 (3.3%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Gastrointestinal haemorrhage | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Intestinal obstruction | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| General disorders | ||||||||||||||
| Fatigue | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Feeling cold | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Gait disturbance | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Malaise | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Oedema peripheral | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Bile duct stone | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Cholelithiasis | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Gastroenteritis | 1/36 (2.8%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Urinary tract infection | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Clavicle fracture | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Humerus fracture | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Dehydration | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Decreased appetite | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Intervertebral disc protrusion | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Basal cell carcinoma | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Carcinoid tumour pulmonary | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Lung cancer metastatic | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Lung neoplasm malignant | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Non-Hodgkins lymphoma | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Prostate cancer | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Squamous cell carcinoma | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Uterine cancer | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Dizziness | 1/36 (2.8%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Syncope | 1/36 (2.8%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Vasogenic cerebral oedema | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Ataxia | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Balance disorder | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Bradykinesia | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Cerebrovascular accident | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Convulsion | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Dementia Alzheimers type | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Dystonia | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Embolic stroke | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Headache | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Transient ischaemic attack | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Agitation | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Confusional state | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Delusion | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Hallucination | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Restlessness | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Renal failure acute | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Stress urinary incontinence | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Pulmonary embolism | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Skin erosion | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Hypotension | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Orthostatic hypotension | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Vasculitis | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/36 (94.4%) | 48/60 (80%) | 35/40 (87.5%) | 28/35 (80%) | 10/12 (83.3%) | 40/44 (90.9%) | 17/17 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 1/36 (2.8%) | 1/60 (1.7%) | 1/40 (2.5%) | 1/35 (2.9%) | 0/12 (0%) | 2/44 (4.5%) | 1/17 (5.9%) | |||||||
| Iron deficiency anaemia | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Eye disorders | ||||||||||||||
| Cataract | 0/36 (0%) | 3/60 (5%) | 1/40 (2.5%) | 1/35 (2.9%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Eye movement disorder | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Diarrhoea | 10/36 (27.8%) | 6/60 (10%) | 4/40 (10%) | 4/35 (11.4%) | 2/12 (16.7%) | 3/44 (6.8%) | 1/17 (5.9%) | |||||||
| Nausea | 5/36 (13.9%) | 9/60 (15%) | 1/40 (2.5%) | 2/35 (5.7%) | 0/12 (0%) | 5/44 (11.4%) | 1/17 (5.9%) | |||||||
| Vomiting | 5/36 (13.9%) | 4/60 (6.7%) | 1/40 (2.5%) | 0/35 (0%) | 2/12 (16.7%) | 5/44 (11.4%) | 0/17 (0%) | |||||||
| Abdominal pain | 0/36 (0%) | 4/60 (6.7%) | 0/40 (0%) | 2/35 (5.7%) | 1/12 (8.3%) | 2/44 (4.5%) | 0/17 (0%) | |||||||
| Constipation | 0/36 (0%) | 2/60 (3.3%) | 1/40 (2.5%) | 0/35 (0%) | 2/12 (16.7%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Gastrooesophageal reflux disease | 0/36 (0%) | 1/60 (1.7%) | 2/40 (5%) | 0/35 (0%) | 2/12 (16.7%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Haemorrhoids | 1/36 (2.8%) | 1/60 (1.7%) | 1/40 (2.5%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Functional gastrointestinal disorder | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| General disorders | ||||||||||||||
| Injection site pain | 7/36 (19.4%) | 17/60 (28.3%) | 9/40 (22.5%) | 4/35 (11.4%) | 1/12 (8.3%) | 6/44 (13.6%) | 0/17 (0%) | |||||||
| Fatigue | 5/36 (13.9%) | 7/60 (11.7%) | 4/40 (10%) | 1/35 (2.9%) | 0/12 (0%) | 5/44 (11.4%) | 1/17 (5.9%) | |||||||
| Injection site erythema | 7/36 (19.4%) | 9/60 (15%) | 6/40 (15%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Injection site swelling | 2/36 (5.6%) | 6/60 (10%) | 7/40 (17.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Asthenia | 1/36 (2.8%) | 2/60 (3.3%) | 1/40 (2.5%) | 3/35 (8.6%) | 2/12 (16.7%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Oedema peripheral | 2/36 (5.6%) | 2/60 (3.3%) | 2/40 (5%) | 1/35 (2.9%) | 1/12 (8.3%) | 2/44 (4.5%) | 0/17 (0%) | |||||||
| Injection site pruritus | 1/36 (2.8%) | 3/60 (5%) | 3/40 (7.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Gait disturbance | 1/36 (2.8%) | 3/60 (5%) | 0/40 (0%) | 2/35 (5.7%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Injection site induration | 0/36 (0%) | 4/60 (6.7%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Malaise | 2/36 (5.6%) | 1/60 (1.7%) | 1/40 (2.5%) | 0/35 (0%) | 2/12 (16.7%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Injection site bruising | 1/36 (2.8%) | 0/60 (0%) | 2/40 (5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Injection site reaction | 3/36 (8.3%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Injection site warmth | 1/36 (2.8%) | 3/60 (5%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Pyrexia | 0/36 (0%) | 3/60 (5%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Injection site inflammation | 0/36 (0%) | 0/60 (0%) | 2/40 (5%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Irritability | 2/36 (5.6%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Injection site haemorrhage | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Infections and infestations | ||||||||||||||
| Urinary tract infection | 3/36 (8.3%) | 6/60 (10%) | 2/40 (5%) | 4/35 (11.4%) | 0/12 (0%) | 2/44 (4.5%) | 4/17 (23.5%) | |||||||
| Nasopharyngitis | 4/36 (11.1%) | 6/60 (10%) | 1/40 (2.5%) | 2/35 (5.7%) | 0/12 (0%) | 4/44 (9.1%) | 1/17 (5.9%) | |||||||
| Upper respiratory tract infection | 3/36 (8.3%) | 3/60 (5%) | 5/40 (12.5%) | 3/35 (8.6%) | 1/12 (8.3%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Sinusitis | 0/36 (0%) | 2/60 (3.3%) | 1/40 (2.5%) | 0/35 (0%) | 1/12 (8.3%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Bronchitis | 3/36 (8.3%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Viral upper respiratory tract infection | 1/36 (2.8%) | 2/60 (3.3%) | 0/40 (0%) | 1/35 (2.9%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Influenza | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 4/44 (9.1%) | 0/17 (0%) | |||||||
| Oral herpes | 0/36 (0%) | 2/60 (3.3%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Rhinitis | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 2/44 (4.5%) | 0/17 (0%) | |||||||
| Lower respiratory tract infection | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 2/35 (5.7%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Tooth infection | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Fungal skin infection | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Furuncle | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Gingivitis | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Herpes simplex ophthalmic | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Fall | 3/36 (8.3%) | 3/60 (5%) | 3/40 (7.5%) | 4/35 (11.4%) | 1/12 (8.3%) | 9/44 (20.5%) | 0/17 (0%) | |||||||
| Contusion | 1/36 (2.8%) | 1/60 (1.7%) | 3/40 (7.5%) | 1/35 (2.9%) | 0/12 (0%) | 3/44 (6.8%) | 1/17 (5.9%) | |||||||
| Laceration | 1/36 (2.8%) | 3/60 (5%) | 1/40 (2.5%) | 0/35 (0%) | 1/12 (8.3%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Arthropod bite | 2/36 (5.6%) | 2/60 (3.3%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Procedural pain | 2/36 (5.6%) | 0/60 (0%) | 2/40 (5%) | 1/35 (2.9%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Excoriation | 0/36 (0%) | 3/60 (5%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Wound | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 1/12 (8.3%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Thermal burn | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Skin injury | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Spinal compression fracture | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Tooth fracture | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Investigations | ||||||||||||||
| Weight decreased | 1/36 (2.8%) | 4/60 (6.7%) | 2/40 (5%) | 0/35 (0%) | 2/12 (16.7%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Weight increased | 1/36 (2.8%) | 1/60 (1.7%) | 1/40 (2.5%) | 2/35 (5.7%) | 0/12 (0%) | 2/44 (4.5%) | 1/17 (5.9%) | |||||||
| Blood creatine phosphokinase increased | 3/36 (8.3%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Blood urea increased | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Blood albumin decreased | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Blood creatinine increased | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Haematocrit decreased | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Haemoglobin decreased | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Decreased appetite | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 2/12 (16.7%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Hyponatraemia | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Back pain | 2/36 (5.6%) | 5/60 (8.3%) | 3/40 (7.5%) | 4/35 (11.4%) | 0/12 (0%) | 4/44 (9.1%) | 3/17 (17.6%) | |||||||
| Arthralgia | 2/36 (5.6%) | 5/60 (8.3%) | 4/40 (10%) | 1/35 (2.9%) | 0/12 (0%) | 2/44 (4.5%) | 2/17 (11.8%) | |||||||
| Musculoskeletal pain | 1/36 (2.8%) | 3/60 (5%) | 2/40 (5%) | 2/35 (5.7%) | 0/12 (0%) | 4/44 (9.1%) | 0/17 (0%) | |||||||
| Pain in extremity | 4/36 (11.1%) | 3/60 (5%) | 1/40 (2.5%) | 2/35 (5.7%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Osteoarthritis | 1/36 (2.8%) | 2/60 (3.3%) | 4/40 (10%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Muscle spasms | 1/36 (2.8%) | 1/60 (1.7%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Osteoporosis | 1/36 (2.8%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 1/12 (8.3%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Bursitis | 1/36 (2.8%) | 0/60 (0%) | 2/40 (5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Arthritis | 0/36 (0%) | 0/60 (0%) | 2/40 (5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Torticollis | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Squamous cell carcinoma | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 3/35 (8.6%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Basal cell carcinoma | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 1/35 (2.9%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 3/36 (8.3%) | 14/60 (23.3%) | 4/40 (10%) | 2/35 (5.7%) | 0/12 (0%) | 8/44 (18.2%) | 1/17 (5.9%) | |||||||
| Dizziness | 3/36 (8.3%) | 7/60 (11.7%) | 4/40 (10%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Cognitive disorder | 1/36 (2.8%) | 3/60 (5%) | 1/40 (2.5%) | 1/35 (2.9%) | 0/12 (0%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Somnolence | 1/36 (2.8%) | 2/60 (3.3%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Syncope | 0/36 (0%) | 2/60 (3.3%) | 3/40 (7.5%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Aphasia | 2/36 (5.6%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Dementia Alzheimers type | 1/36 (2.8%) | 0/60 (0%) | 1/40 (2.5%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Apraxia | 2/36 (5.6%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Cerebral microhaemorrhage | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 1/17 (5.9%) | |||||||
| Lethargy | 3/36 (8.3%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Presyncope | 1/36 (2.8%) | 0/60 (0%) | 2/40 (5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Clonus | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Extrapyramidal disorder | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 1/35 (2.9%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Sciatica | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 2/35 (5.7%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Amnesia | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Memory impairment | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Mental impairment | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Migraine | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Speech disorder | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Unresponsive to stimuli | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Depression | 5/36 (13.9%) | 4/60 (6.7%) | 4/40 (10%) | 8/35 (22.9%) | 3/12 (25%) | 5/44 (11.4%) | 1/17 (5.9%) | |||||||
| Agitation | 4/36 (11.1%) | 4/60 (6.7%) | 0/40 (0%) | 5/35 (14.3%) | 2/12 (16.7%) | 4/44 (9.1%) | 2/17 (11.8%) | |||||||
| Anxiety | 3/36 (8.3%) | 5/60 (8.3%) | 1/40 (2.5%) | 2/35 (5.7%) | 2/12 (16.7%) | 2/44 (4.5%) | 0/17 (0%) | |||||||
| Confusional state | 2/36 (5.6%) | 1/60 (1.7%) | 0/40 (0%) | 2/35 (5.7%) | 0/12 (0%) | 2/44 (4.5%) | 0/17 (0%) | |||||||
| Abnormal dreams | 3/36 (8.3%) | 0/60 (0%) | 1/40 (2.5%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Aggression | 1/36 (2.8%) | 1/60 (1.7%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 2/17 (11.8%) | |||||||
| Delusion | 1/36 (2.8%) | 1/60 (1.7%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 2/17 (11.8%) | |||||||
| Hallucination | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 2/44 (4.5%) | 1/17 (5.9%) | |||||||
| Hallucination, visual | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 2/35 (5.7%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Paranoia | 2/36 (5.6%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Delirium | 1/36 (2.8%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Depressive symptom | 0/36 (0%) | 0/60 (0%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 2/17 (11.8%) | |||||||
| Disorientation | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Hallucination, auditory | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Urinary incontinence | 2/36 (5.6%) | 1/60 (1.7%) | 3/40 (7.5%) | 2/35 (5.7%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Incontinence | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Hydronephrosis | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Renal failure | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Reproductive system and breast disorders | ||||||||||||||
| Breast swelling | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 6/36 (16.7%) | 4/60 (6.7%) | 2/40 (5%) | 2/35 (5.7%) | 2/12 (16.7%) | 4/44 (9.1%) | 2/17 (11.8%) | |||||||
| Oropharyngeal pain | 1/36 (2.8%) | 3/60 (5%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Rhinorrhoea | 2/36 (5.6%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Chronic obstructive pulmonary disease | 0/36 (0%) | 1/60 (1.7%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Pleural effusion | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Rash | 3/36 (8.3%) | 1/60 (1.7%) | 1/40 (2.5%) | 2/35 (5.7%) | 0/12 (0%) | 1/44 (2.3%) | 0/17 (0%) | |||||||
| Skin lesion | 4/36 (11.1%) | 3/60 (5%) | 0/40 (0%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Hyperhidrosis | 1/36 (2.8%) | 0/60 (0%) | 1/40 (2.5%) | 1/35 (2.9%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Ecchymosis | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Petechiae | 1/36 (2.8%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Intertrigo | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Rash pruritic | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 1/12 (8.3%) | 0/44 (0%) | 0/17 (0%) | |||||||
| Urticaria | 0/36 (0%) | 0/60 (0%) | 0/40 (0%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 1/17 (5.9%) | |||||||
| Vascular disorders | ||||||||||||||
| Hypertension | 4/36 (11.1%) | 3/60 (5%) | 1/40 (2.5%) | 3/35 (8.6%) | 1/12 (8.3%) | 5/44 (11.4%) | 1/17 (5.9%) | |||||||
| Haematoma | 0/36 (0%) | 1/60 (1.7%) | 1/40 (2.5%) | 0/35 (0%) | 0/12 (0%) | 4/44 (9.1%) | 1/17 (5.9%) | |||||||
| Orthostatic hypotension | 0/36 (0%) | 0/60 (0%) | 2/40 (5%) | 0/35 (0%) | 0/12 (0%) | 0/44 (0%) | 0/17 (0%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479557
Other Study ID Numbers:
- 3134K1-200
- B2571004
- 2006-002061-39
First Posted:
May 28, 2007
Last Update Posted:
Jan 1, 2016
Last Verified:
Nov 1, 2015