Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Study Details
Study Description
Brief Summary
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.
Primary objective:
- To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection.
Secondary Objectives:
Efficacy:
-
To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days.
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To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections.
Immunogenicity:
- To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60.
Safety:
- To describe the safety profile of all participants who received at least 1 injection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
The study was designed as an event-driven group sequential protocol with 4 interim analyses at defined information milestones and a final analysis when a specific number of clinical endpoints are reached. Analyses of trial futility (non-efficacy) were to be performed at the first 2 interim analyses, and the study was to be stopped if either of those analyses provided robust and compelling evidence that meaningful levels of vaccine efficacy (VE) would not be demonstrated.
Following completion of the first interim analysis (50 cases of confirmed CDI observed), the futility criterion was met and in accordance with IDMC recommendation, enrollment and further vaccination ceased in November 2017.
Due to the early termination of the study, some of the planned secondary efficacy endpoints could not be analyzed as all planned data were not collected.
Participants were randomized to receive either the candidate vaccine or a placebo that was to be administered in a 3-dose schedule. At the time of group assignment, 928 participants (10% of total enrollment) were randomized to an immunogenicity subset; and 1859 participants (20% of total enrollment) were randomized to a reactogenicity subset.
Safety was assessed in all participants in terms of unsolicited adverse events from Day 0 to Day 60, as well as serious adverse events (SAEs) throughout the study. Solicited adverse reactions were collected for 6 days following each injection in the reactogenicity subset.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: C. difficile Vaccine Group Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Biological: C. difficile Toxoid Vaccine
0.5 mL, Intramuscular
|
Placebo Comparator: Placebo Group Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Biological: Placebo: 0.9% normal saline
0.5 mL, Intramuscular
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases [Up to 3 years post injection 1]
Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
Secondary Outcome Measures
- Number of Participants With Severe PCR-Confirmed Primary CDI Cases [Up to 3 years post injection 1]
Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever >= 38.5 degree Celsius (°C), white blood cell count >= 15,000 cells/mm^3, ileus, pseudomembranous colitis, serum albumin <3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.
- Number of Participants With Loose Stool Episodes [Up to 3 years post injection 1]
Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.
- Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population [Up to 3 years post injection 1]
Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS).
- Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA) [Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110]
Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).
- Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA [Day 60]
Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.
- Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI [Day 0 and Day 60]
Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
- Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA) [Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110]
Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.
- Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA [Day 60]
Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.
- Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI [Day 0 and Day 60]
Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
- Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions [Day 0 to Day 6 after any vaccination]
Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: >= 25 to <=50 mm, Grade 2: >51 to <=100 mm, Grade 3: >100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: >= 38.0°C to <=38.4°C or >= 100.4° Fahrenheit (F) to <=101.1°F, Grade 2: >=38.5°C to <= 38.9°C or >=101.2°F to <=102.0°F, Grade 3: >=39.0°C or >=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged >= 50 years on the day of inclusion
-
Informed consent form had been signed and dated.
-
Attended all scheduled visits and complied with all trial procedures.
-
Covered by health insurance (if required).
-
Must fulfill at least 1 of the following criteria
Risk Stratum 1:
-
Had at least 2 hospital stays, each lasting at least >= 24 hours, in the 12 months before enrollment, and
-
Had received systemic (not topical) antibiotics in the 12 months before enrollment, or
Risk Stratum 2:
-
Was anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay was planned to be >= 72 hours for a surgery involving 1 of the following:
-
Kidney/bladder/urinary system
-
Musculoskeletal system
-
Respiratory system
-
Circulatory system
-
Central nervous system.
Exclusion Criteria:
-
Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).
-
Participation in the 4 weeks preceding the first trial vaccination or participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
-
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
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Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies.
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Diarrhea on day of enrollment.
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Self-reported current or prior CDI episode.
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Anticipated or current receipt of kidney dialysis treatment.
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History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria).
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History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea as a symptom), colostomy, or small or large intestine bowel surgery where resection was performed.
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Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding).
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Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
-
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
-
Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
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Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
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Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator.
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Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
-
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>= 100.4°Fahrenheit]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
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Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Huntsville | Alabama | United States | 35803 | |
2 | Investigational Site 104 | Mobile | Alabama | United States | 36608 |
3 | Flagstaff | Arizona | United States | 86001 | |
4 | Investigational Site 194 | Phoenix | Arizona | United States | 85018 |
5 | Investigational Site 503 | Surprise | Arizona | United States | 85374 |
6 | Little Rock | Arkansas | United States | 72205 | |
7 | Bakersfield | California | United States | 93301 | |
8 | Banning | California | United States | 92220 | |
9 | Garden Grove | California | United States | 92844 | |
10 | La Mesa | California | United States | 91942 | |
11 | Investigational Site 534 | Los Angeles | California | United States | 90022 |
12 | Investigational Site 051 | Los Angeles | California | United States | 90027 |
13 | Modesto | California | United States | 95350 | |
14 | Redding | California | United States | 96001 | |
15 | Sacramento | California | United States | 95817 | |
16 | Investigational Site 504 | Simi Valley | California | United States | 93065 |
17 | Investigational Site 057 | Stanford | California | United States | 94305 |
18 | Investigational Site 176 | Upland | California | United States | 91786 |
19 | Ventura | California | United States | 93003 | |
20 | Investigational Site 546 | Wheat Ridge | Colorado | United States | 90033 |
21 | Bristol | Connecticut | United States | 06010 | |
22 | Danbury | Connecticut | United States | 06810 | |
23 | Investigational Site 143 | Bradenton | Florida | United States | 34209 |
24 | Investigational Site 187 | Brandon | Florida | United States | 33511 |
25 | Investigational Site 075 | Clearwater | Florida | United States | 33756 |
26 | Investigational Site 517 | Clearwater | Florida | United States | 33765 |
27 | Investigational Site 055 | Crystal River | Florida | United States | 34429 |
28 | DeLand | Florida | United States | 32720 | |
29 | Investigational Site 506 | Gainesville | Florida | United States | 32607 |
30 | Investigational Site 099 | Hialeah | Florida | United States | 33012 |
31 | Investigational Site 009 | Jacksonville | Florida | United States | 32216 |
32 | Lauderdale Lakes | Florida | United States | 33319 | |
33 | Miami | Florida | United States | 33165 | |
34 | Orange Park | Florida | United States | 32073 | |
35 | Investigational Site 112 | Pensacola | Florida | United States | 32504 |
36 | Port Saint Lucie | Florida | United States | 34987 | |
37 | Investigational Site 040 | Saint Petersburg | Florida | United States | 33709 |
38 | Investigational Site 114 | Saint Petersburg | Florida | United States | 33713 |
39 | Investigational Site 088 | Sarasota | Florida | United States | 34239 |
40 | Tamarac | Florida | United States | 33321 | |
41 | Tampa | Florida | United States | 33612 | |
42 | West Palm Beach | Florida | United States | 33401 | |
43 | Investigational Site 149 | Augusta | Georgia | United States | 30912 |
44 | Investigational Site 529 | Decatur | Georgia | United States | 30030 |
45 | Macon | Georgia | United States | 31201 | |
46 | Investigational Site 010 | Savannah | Georgia | United States | 31406 |
47 | Investigational Site 049 | Idaho Falls | Idaho | United States | 83494 |
48 | Investigational Site 543 | Pocatello | Idaho | United States | 83201 |
49 | Evanston | Illinois | United States | 60201 | |
50 | Peoria | Illinois | United States | 61602 | |
51 | Peoria | Illinois | United States | 61614 | |
52 | Anderson | Indiana | United States | 46011 | |
53 | Investigational Site 101 | Iowa City | Iowa | United States | 52242 |
54 | Topeka | Kansas | United States | 66606 | |
55 | Louisville | Kentucky | United States | 40202 | |
56 | Investigational Site 091 | Metairie | Louisiana | United States | 70006 |
57 | Investigational Site 084 | New Orleans | Louisiana | United States | 70121 |
58 | Opelousas | Louisiana | United States | 70570 | |
59 | Investigational Site 077 | Shreveport | Louisiana | United States | 71101 |
60 | Auburn | Maine | United States | 04210 | |
61 | Baltimore | Maryland | United States | 21224 | |
62 | Investigational Site 002 | Boston | Massachusetts | United States | 02215 |
63 | Investigational Site 035 | West Roxbury | Massachusetts | United States | 02132 |
64 | Investigational Site 190 | Ann Arbor | Michigan | United States | 48106 |
65 | Investigational Site 175 | Detroit | Michigan | United States | 48202 |
66 | Investigational Site 183 | Flint | Michigan | United States | 48504 |
67 | Grosse Pointe Woods | Michigan | United States | 48236 | |
68 | Kalamazoo | Michigan | United States | 49007 | |
69 | Livonia | Michigan | United States | 48152 | |
70 | Investigational Site 069 | Royal Oak | Michigan | United States | 48073 |
71 | Stevensville | Michigan | United States | 49127 | |
72 | Troy | Michigan | United States | 48098 | |
73 | Butte | Montana | United States | 59701 | |
74 | Investigational Site 189 | Hillsborough | New Jersey | United States | 8844 |
75 | Investigational Site 044 | Neptune | New Jersey | United States | 07753 |
76 | Teaneck | New Jersey | United States | 07666 | |
77 | Albuquerque | New Mexico | United States | 27103 | |
78 | Albuquerque | New Mexico | United States | 87102 | |
79 | Bronx | New York | United States | 10467 | |
80 | Investigational Site 013 | Bronx | New York | United States | 10468 |
81 | Investigational Site 022 | Endwell | New York | United States | 13760 |
82 | Rochester | New York | United States | 14621 | |
83 | Rochester | New York | United States | 14642 | |
84 | Syracuse | New York | United States | 13210 | |
85 | Investigational Site 146 | Asheville | North Carolina | United States | 28805 |
86 | Cary | North Carolina | United States | 27518 | |
87 | Charlotte | North Carolina | United States | 28209 | |
88 | Hickory | North Carolina | United States | 28602 | |
89 | Raleigh | North Carolina | United States | 27612 | |
90 | Raleigh | North Carolina | United States | 48202 | |
91 | Statesville | North Carolina | United States | 28625 | |
92 | Wilmington | North Carolina | United States | 28401 | |
93 | Winston-Salem | North Carolina | United States | 27103 | |
94 | Investigational Site 031 | Fargo | North Dakota | United States | 58104 |
95 | Fargo | North Dakota | United States | 58122 | |
96 | Investigational Site 523 | Canton | Ohio | United States | 44710 |
97 | Cincinnati | Ohio | United States | 45219 | |
98 | Cleveland | Ohio | United States | 44106 | |
99 | Investigational Site 129 | Cleveland | Ohio | United States | 44109 |
100 | Cleveland | Ohio | United States | 44118 | |
101 | Investigational Site 003 | Columbus | Ohio | United States | 43215 |
102 | Investigational Site 061 | Dayton | Ohio | United States | 45419 |
103 | Dayton | Ohio | United States | 45428 | |
104 | Kettering | Ohio | United States | 45429 | |
105 | Marion | Ohio | United States | 43302 | |
106 | Investigational Site 095 | Middletown | Ohio | United States | 45005 |
107 | Bend | Oregon | United States | 97701 | |
108 | Investigational Site 528 | Camp Hill | Pennsylvania | United States | 17011 |
109 | Hershey | Pennsylvania | United States | 17033 | |
110 | Philadelphia | Pennsylvania | United States | 19140 | |
111 | Pittsburgh | Pennsylvania | United States | 15212 | |
112 | Pittsburgh | Pennsylvania | United States | 15240 | |
113 | Investigational Site 083 | Uniontown | Pennsylvania | United States | 15401 |
114 | West Reading | Pennsylvania | United States | 19611 | |
115 | Investigational Site 020 | Wilkes-Barre | Pennsylvania | United States | 18711 |
116 | Investigational Site 050 | Pawtucket | Rhode Island | United States | 02860 |
117 | Providence | Rhode Island | United States | 02906 | |
118 | Providence | Rhode Island | United States | 02908 | |
119 | Investigational Site 540 | Charleston | South Carolina | United States | 29407 |
120 | Investigational Site 047 | Mount Pleasant | South Carolina | United States | 29464 |
121 | Investigational Site 180 | Spartanburg | South Carolina | United States | 29303 |
122 | Investigational Site 086 | Rapid City | South Dakota | United States | 57701 |
123 | Franklin | Tennessee | United States | 37067 | |
124 | Jackson | Tennessee | United States | 38305 | |
125 | Nashville | Tennessee | United States | 37082 | |
126 | Nashville | Tennessee | United States | 37203 | |
127 | Investigational Site 544 | Austin | Texas | United States | 78726 |
128 | Corpus Christi | Texas | United States | 78413 | |
129 | Investigational Site 006 | Dallas | Texas | United States | 75216 |
130 | Investigational Site 119 | Fort Worth | Texas | United States | 76104 |
131 | Groesbeck | Texas | United States | 76642 | |
132 | Investigational Site 193 | San Antonio | Texas | United States | 78229 |
133 | Tomball | Texas | United States | 77375 | |
134 | Investigational Site 135 | Orem | Utah | United States | 84058 |
135 | Investigational Site 080 | Salt Lake City | Utah | United States | 84124 |
136 | Investigational Site 012 | Lynchburg | Virginia | United States | 24501 |
137 | Williamsburg | Virginia | United States | 23185 | |
138 | Investigational Site 196 | Winchester | Virginia | United States | 22601 |
139 | Spokane | Washington | United States | 99202 | |
140 | Tacoma | Washington | United States | 98405 | |
141 | Investigational Site 030 | Marshfield | Wisconsin | United States | 54449 |
142 | Weston | Wisconsin | United States | 54476 | |
143 | Westmead | New South Wales | Australia | 2145 | |
144 | Investigational Site 401 | Cairns | Queensland | Australia | 4870 |
145 | Woolloongabba | Queensland | Australia | 4102 | |
146 | Investigational Site 404 | Bedford Park | South Australia | Australia | 5042 |
147 | Investigational Site 403 | Clayton | Victoria | Australia | 3168 |
148 | Nedlands | Western Australia | Australia | 6009 | |
149 | Subiaco | Western Australia | Australia | 6008 | |
150 | Salvador | BA | Brazil | 40420-000 | |
151 | Salvador | BA | Brazil | 41253-190 | |
152 | Aparecida de Goiânia | GO | Brazil | 74935-530 | |
153 | Belo Horizonte | MG | Brazil | 30150-221 | |
154 | Belo Horizonte | MG | Brazil | 30190-130 | |
155 | Juiz De Fora | MG | Brazil | 36010-570 | |
156 | Recife | PE | Brazil | 52020-010 | |
157 | Curitiba | PR | Brazil | 80810-040 | |
158 | Nova Iguaçu | RJ | Brazil | 26030-380 | |
159 | Rio de Janeiro | RJ | Brazil | 22271-100 | |
160 | Natal | RN | Brazil | 59025-600 | |
161 | Canoas | RS | Brazil | 92425-900 | |
162 | Porto Alegre | RS | Brazil | 90035-003 | |
163 | Santo Andre | SP | Brazil | 09060-650 | |
164 | Campinas | Brazil | 13020431 | ||
165 | New Westminster | British Columbia | Canada | V3L 3W7 | |
166 | Investigational Site 156 | Surrey | British Columbia | Canada | V3V 1Z2 |
167 | Investigational Site 158 | Vancouver | British Columbia | Canada | V5Z IM9 |
168 | Winnipeg | Manitoba | Canada | R3A IR9 | |
169 | Halifax | Nova Scotia | Canada | B3K 6R8 | |
170 | Investigational Site 163 | Truro | Nova Scotia | Canada | B2N 1L2 |
171 | Guelph | Ontario | Canada | N1H 1B1 | |
172 | Toronto | Ontario | Canada | M5G 1X5 | |
173 | Montreal | Quebec | Canada | H3T 1E2 | |
174 | Pierrefonds | Quebec | Canada | H9H 4Y6 | |
175 | Investigational Site 152 | Québec | Quebec | Canada | G1E 7G9 |
176 | Investigational Site 151 | Sherbrooke | Quebec | Canada | J1H5N4 |
177 | Investigational Site 161 | Trois-Rivières | Quebec | Canada | G8Z 3R9 |
178 | Barranquilla | Alantico | Colombia | ||
179 | Medellin | Antioquia | Colombia | ||
180 | Bogota | Ditrito Capital | Colombia | ||
181 | Bogota | Ditrito | Colombia | ||
182 | Armenia | Quindio | Colombia | ||
183 | Bucaramanga | Santander | Colombia | ||
184 | Floridablanca | Santander | Colombia | ||
185 | Yopal | Colombia | |||
186 | San José | Costa Rica | 250-1000 | ||
187 | Investigational Site 215 | Aarhus | Denmark | 8200 | |
188 | Investigational Site 347 | Santo Domingo | Dominican Republic | ||
189 | Espoo | Finland | FIN-02100 | ||
190 | Helsinki | Finland | FIN-00100 | ||
191 | Helsinki | Finland | FIN-00930 | ||
192 | Investigational Site 203 | Järvenpää | Finland | FIN-04400 | |
193 | Kokkola | Finland | 67100 | ||
194 | Oulu | Finland | FIN-90220 | ||
195 | Pori | Finland | 28100 | ||
196 | Seinajoki | Finland | 60100 | ||
197 | Investigational Site 201 | Tampere | Finland | FIN-33100 | |
198 | Investigational Site 202 | Turku | Finland | FIN-20520 | |
199 | Vantaa | Finland | FIN-01300 | ||
200 | Investigational Site 230 | Dijon | France | 21079 | |
201 | Lille | France | 49100 | ||
202 | Limoges | France | 87042 | ||
203 | Lyon | France | 69004 | ||
204 | Montpellier | France | 34295 | ||
205 | Orleans | France | 45100 | ||
206 | Investigational Site 221 | Paris | France | 75014 | |
207 | Investigational Site 229 | Pringy | France | 21079 | |
208 | Saint Etienne | France | 42055 | ||
209 | Investigational Site 223 | St Priest en Jarez | France | 42270 | |
210 | Tourcoing | France | 59208 | ||
211 | Investigational Site 232 | Tours | France | 37044 | |
212 | Munich | Bavaria | Germany | 81675 | |
213 | Investigational Site 242 | Wurzburg | Bayern | Germany | 97074 |
214 | Investigational Site 244 | Deggingen | BW | Germany | 73326 |
215 | Cologne | NRW | Germany | 50937 | |
216 | Leipzig | Sachsen | Germany | 04109 | |
217 | Jena | Thuringia | Germany | 07747 | |
218 | Berlin | Germany | 10629 | ||
219 | Berlin | Germany | 13347 | ||
220 | Essen | Germany | 45355 | ||
221 | Goch | Germany | 47574 | ||
222 | Investigational Site 247 | Hamburg | Germany | 20359 | |
223 | Investigational Site 245 | Hamburg | Germany | 22143 | |
224 | Leipzig | Germany | 97074 | ||
225 | Guatemala | Guatemala | 1001 | ||
226 | Investigational Site 450 | Aichi | Japan | 491-8551 | |
227 | Investigational Site 468 | Chiba | Japan | 278-0004 | |
228 | Investigational Site 467 | Fukui | Japan | 910-0067 | |
229 | Investigational Site 464 | Fukuoka | Japan | 800-0344 | |
230 | Investigational Site 465 | Fukuoka | Japan | 814-8525 | |
231 | Investigational Site 466 | Fukuoka | Japan | 838-0069 | |
232 | Investigational Site 457 | Gunma | Japan | 371-0014 | |
233 | Investigational Site 455 | Hyōgo | Japan | 666-0125 | |
234 | Investigational Site 453 | Ibaraki | Japan | 300-0028 | |
235 | Investigational Site 460 | Kyoto | Japan | 611-0041 | |
236 | Investigational Site 454 | Kyoto | Japan | 613-0034 | |
237 | Investigational Site 456 | Nagano | Japan | 382-0091 | |
238 | Investigational Site 452 | Nagano | Japan | 390-8601 | |
239 | Investigational Site 458 | Nagano | Japan | 392-8510 | |
240 | Investigational Site 469 | Okinawa | Japan | 904-2293 | |
241 | Investigational Site 459 | Saitama | Japan | 348-0044 | |
242 | Investigational Site 467 | Shimonoseki | Japan | 750-8520 | |
243 | Investigational Site 451 | Tokyo | Japan | 171-0014 | |
244 | Investigational Site 463 | Yamaguchi | Japan | 750-8520 | |
245 | Investigational Site 461 | Ōsaka | Japan | 596-8522 | |
246 | Seoul | Gangnam-gu | Korea, Republic of | 135-710 | |
247 | Investigational Site 407 | Wŏnju | Gangwon-do | Korea, Republic of | 26427 |
248 | Investigational Site 413 | Ansan | Gyeonggi-do | Korea, Republic of | 15355 |
249 | Daegu | Jung-Gu | Korea, Republic of | 700-721 | |
250 | Investigational Site 427 | Incheon | Namdong-gu | Korea, Republic of | 22332 |
251 | Seoul | Seocho-gu | Korea, Republic of | 137-701 | |
252 | Seoul | Seodaemun-gu | Korea, Republic of | 120-752 | |
253 | Seoul | Seongbuk-gu | Korea, Republic of | 136-705 | |
254 | Seoul | Seongdong-gu | Korea, Republic of | 132-792 | |
255 | Seoul | Songpa-gu | Korea, Republic of | 138-736 | |
256 | Investigational Site 446 | Busan | Korea, Republic of | 49201 | |
257 | Cheongju | Korea, Republic of | 361-711 | ||
258 | Investigational Site 439 | Gyeonggi-do | Korea, Republic of | 16247 | |
259 | Gyeonggi-do | Korea, Republic of | 443-380 | ||
260 | Investigational Site 412 | Incheon | Korea, Republic of | 21565 | |
261 | Investigational Site 409 | Seoul | Korea, Republic of | 2841 | |
262 | Investigational Site 408 | Seoul | Korea, Republic of | 3722 | |
263 | Investigational Site 415 | Seoul | Korea, Republic of | 5355 | |
264 | Investigational Site 418 | Seoul | Korea, Republic of | 5505 | |
265 | Investigational Site 411 | Seoul | Korea, Republic of | 6351 | |
266 | Investigational Site 437 | Seoul | Korea, Republic of | 7441 | |
267 | Investigational Site 438 | Seoul | Korea, Republic of | 8308 | |
268 | Aguascalientes | AGS | Mexico | 20230 | |
269 | Tijuana | Baja California | Mexico | 22320 | |
270 | Investigational Site 325 | Mexico City | D.f. | Mexico | 14000 |
271 | Investigational Site 329 | Mexico City | D.f. | Mexico | 14080 |
272 | Investigational Site 352 | Ecatepec | Estado De Mexico | Mexico | 55076 |
273 | Investigational Site 324 | Guadalajara | Jalisco | Mexico | 44280 |
274 | Investigational Site 351 | Cuernavaca | Morelos | Mexico | 62290 |
275 | Monterrey | NL | Mexico | 64460 | |
276 | San Luis Potosi | SLP | Mexico | 78240 | |
277 | Investigational Site 363 | Ciudad Victoria | Tamaulipas | Mexico | |
278 | Investigational Site 326 | Durango | Mexico | 34000 | |
279 | Morelos | Mexico | |||
280 | San Luis Potosi | Mexico | 78240 | ||
281 | Investigational Site 354 | Panama City | Panama | ||
282 | Investigational Site 364 | Trujillo | La Libertad | Peru | 130101 |
283 | Investigational Site 332 | Jesus Maria | Lima | Peru | lima 11 |
284 | Lima Cercado | Lima | Peru | ||
285 | Investigational Site 334 | San Martín de Porres | Lima | Peru | lima 31 |
286 | Surquillo | Lima | Peru | ||
287 | Investigational Site 356 | Lima | Peru | callao 2 | |
288 | Investigational Site 355 | Lima | Peru | lima 1 | |
289 | Lima | Peru | |||
290 | Investigational Site 365 | Piura | Peru | 200101 | |
291 | Alabang | Philippines | 1770 | ||
292 | Dasmarinas | Philippines | 4114 | ||
293 | Manila | Philippines | 1000 | ||
294 | Manila | Philippines | 1004 | ||
295 | Pasig City | Philippines | 1600 | ||
296 | Quezon City | Philippines | 1100 | ||
297 | Quezon City | Philippines | 1101 | ||
298 | Investigational Site 284 | Bydgoszcz | Poland | 85-863 | |
299 | Investigational Site 283 | Nowy Duninów | Poland | 09-505 | |
300 | Investigational Site 171 | Bayamon | Puerto Rico | 00960 | |
301 | Bayamon | Puerto Rico | 00961 | ||
302 | Singapore | Singapore | 119074 | ||
303 | Investigational Site 419 | Singapore | Singapore | 119228 | |
304 | Singapore | Singapore | 169608 | ||
305 | Investigational Site 428 | Singapore | Singapore | 308433 | |
306 | Investigational Site 445 | Singapore | Singapore | 768828 | |
307 | Investigational Site 294 | Cordoba | Spain | 14004 | |
308 | Investigational Site 293 | Santander | Spain | 39008 | |
309 | Investigational Site 292 | Terrassa | Spain | 08221 | |
310 | Investigational Site 295 | Vigo | Spain | 36312 | |
311 | Göthenburg | SWE | Sweden | 41685 | |
312 | Stockholm | Sweden | 11157 | ||
313 | Umea | Sweden | 90185 | ||
314 | Kaohsiung | Taiwan | 813 | ||
315 | Investigational Site 426 | New Taipei City | Taiwan | 22056 | |
316 | New Taipei City | Taiwan | 23156 | ||
317 | Investigational Site 429 | Taichung City | Taiwan | 40201 | |
318 | Investigational Site 421 | Tainan | Taiwan | 71004 | |
319 | Investigational Site 425 | Taipei | Taiwan | 10002 | |
320 | Tiachung | Taiwan | 404 | ||
321 | Investigational Site 443 | Bangkok | Thailand | 10330 | |
322 | Investigational Site 442 | Bangkok | Thailand | 10400 | |
323 | Investigational Site 441 | Khon Kaen | Thailand | 40002 | |
324 | Investigational Site 276 | Blackpool | United Kingdom | FY3 7EN | |
325 | Blackpool | United Kingdom | FY3 8NR | ||
326 | Investigational Site 277 | Coventry | United Kingdom | CV2 2DX | |
327 | Harrow | United Kingdom | HA1 3UJ | ||
328 | Investigational Site 281 | Leeds | United Kingdom | LS9 7TF | |
329 | Liverpool | United Kingdom | L78XP | ||
330 | Investigational Site 271 | London | United Kingdom | SW17 0RE | |
331 | Manchester | United Kingdom | M8 5RB | ||
332 | Middlesex | United Kingdom | HA1 3UJ | ||
333 | North Shields | United Kingdom | NE29 8NH | ||
334 | Investigational Site 275 | Penzance | United Kingdom | TR19 7HX | |
335 | Stoke on Trent | United Kingdom | SR53SY |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- H-030-014
- 2013-000775-32
- U1111-1127-7162
Study Results
Participant Flow
Recruitment Details | Study participants were enrolled in the study from 30 July 2013 to 17 November 2017. |
---|---|
Pre-assignment Detail | A total of 9302 participants were enrolled and randomized in the study. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Period Title: Overall Study | ||
STARTED | 6201 | 3101 |
Safety Population | 6113 | 3057 |
COMPLETED | 4809 | 2370 |
NOT COMPLETED | 1392 | 731 |
Baseline Characteristics
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group | Total |
---|---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Total of all reporting groups |
Overall Participants | 6201 | 3101 | 9302 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
65.9
(8.86)
|
65.8
(8.87)
|
65.8
(8.86)
|
Sex: Female, Male (Count of Participants) | |||
Female |
2629
42.4%
|
1294
41.7%
|
3923
42.2%
|
Male |
3572
57.6%
|
1807
58.3%
|
5379
57.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
330
5.3%
|
171
5.5%
|
501
5.4%
|
Not Hispanic or Latino |
2780
44.8%
|
1390
44.8%
|
4170
44.8%
|
Unknown or Not Reported |
3091
49.8%
|
1540
49.7%
|
4631
49.8%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
6
0.1%
|
6
0.2%
|
12
0.1%
|
Asian |
795
12.8%
|
398
12.8%
|
1193
12.8%
|
Native Hawaiian or Other Pacific Islander |
5
0.1%
|
4
0.1%
|
9
0.1%
|
Black or African American |
206
3.3%
|
102
3.3%
|
308
3.3%
|
White |
2983
48.1%
|
1487
48%
|
4470
48.1%
|
More than one race |
8
0.1%
|
5
0.2%
|
13
0.1%
|
Unknown or Not Reported |
2198
35.4%
|
1099
35.4%
|
3297
35.4%
|
Outcome Measures
Title | Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases |
---|---|
Description | Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. |
Time Frame | Up to 3 years post injection 1 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least 1 injection and were analyzed according to the group to which they were randomized. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 6173 | 3085 |
Count of Participants [Participants] |
34
0.5%
|
16
0.5%
|
Title | Number of Participants With Severe PCR-Confirmed Primary CDI Cases |
---|---|
Description | Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever >= 38.5 degree Celsius (°C), white blood cell count >= 15,000 cells/mm^3, ileus, pseudomembranous colitis, serum albumin <3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis. |
Time Frame | Up to 3 years post injection 1 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 34 | 16 |
Count of Participants [Participants] |
9
0.1%
|
6
0.2%
|
Title | Number of Participants With Loose Stool Episodes |
---|---|
Description | Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported. |
Time Frame | Up to 3 years post injection 1 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on participants with protocol-defined PCR confirmed CDI cases. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 34 | 16 |
<3 |
0
0%
|
0
0%
|
3 to 6 |
7
0.1%
|
4
0.1%
|
7 to 10 |
7
0.1%
|
2
0.1%
|
11 to 15 |
7
0.1%
|
4
0.1%
|
>15 |
13
0.2%
|
6
0.2%
|
Title | Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population |
---|---|
Description | Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS). |
Time Frame | Up to 3 years post injection 1 |
Outcome Measure Data
Analysis Population Description |
---|
PPEAS: participants who had at least 1 injection, no relevant protocol deviations (not meet inclusion criteria/ met exclusion criteria, not receive any vaccine/not received in proper time window, received different vaccine than randomized, preparation and / or administration of vaccine not done per protocol, received protocol-restricted therapy). |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 4786 | 2378 |
Count of Participants [Participants] |
23
0.4%
|
13
0.4%
|
Title | Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA) |
---|---|
Description | Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result). |
Time Frame | Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 471 | 236 |
Toxin A ImunnoglobulinG (IgG): Day 0 |
0.957
|
0.999
|
Toxin A IgG: Day 14 |
3.19
|
0.913
|
Toxin A IgG: Day 30 |
12.2
|
0.959
|
Toxin A IgG: Day 60 |
43.7
|
0.933
|
Toxin A IgG: Day 210 |
12.0
|
0.944
|
Toxin A IgG: Day 390 |
6.02
|
0.955
|
Toxin A IgG: Day 570 |
4.50
|
0.908
|
Toxin A IgG: Day 750 |
4.02
|
0.856
|
Toxin A IgG: Day 930 |
3.83
|
0.902
|
Toxin A IgG: Day 1110 |
3.75
|
1.09
|
Toxin B IgG: Day 0 |
1.40
|
1.49
|
Toxin B IgG: Day 14 |
4.36
|
1.56
|
Toxin B IgG: Day 30 |
10.0
|
1.46
|
Toxin B IgG: Day 60 |
24.8
|
1.42
|
Toxin B IgG: Day 210 |
6.62
|
1.31
|
Toxin B IgG: Day 390 |
3.98
|
1.24
|
Toxin B IgG: Day 570 |
3.37
|
1.15
|
Toxin B IgG: Day 750 |
2.86
|
1.11
|
Toxin B IgG: Day 930 |
2.42
|
1.13
|
Toxin B IgG: Day 1110 |
3.46
|
0.966
|
Title | Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA |
---|---|
Description | Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations. |
Time Frame | Day 60 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 436 | 220 |
Toxin A IgG: >=2 |
93.3
1.5%
|
0.9
0%
|
Toxin A IgG: >=4 |
88.9
1.4%
|
0.0
0%
|
Toxin B IgG: >=2 |
82.2
1.3%
|
4.6
0.1%
|
Toxin B IgG: >=4 |
73.2
1.2%
|
0.5
0%
|
Title | Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI |
---|---|
Description | Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. |
Time Frame | Day 0 and Day 60 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, 'number analyzed' = participants with available data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 34 | 16 |
Toxin A IgG: Day 0 |
1.15
|
1.04
|
Toxin A IgG: Day 60 |
42.1
|
1.06
|
Toxin B IgG: Day 0 |
1.41
|
1.05
|
Toxin B IgG: Day 60 |
19.3
|
1.13
|
Title | Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA) |
---|---|
Description | Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution. |
Time Frame | Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 471 | 236 |
Toxin A TNA: Day 0 |
9.86
|
10.1
|
Toxin A TNA: Day 14 |
28.5
|
9.86
|
Toxin A TNA: Day 30 |
50.5
|
9.97
|
Toxin A TNA: Day 60 |
269
|
9.82
|
Toxin A TNA: Day 210 |
269
|
10.3
|
Toxin A TNA: Day 390 |
217
|
10.1
|
Toxin A TNA: Day 570 |
184
|
9.86
|
Toxin A TNA: Day 750 |
186
|
10.2
|
Toxin A TNA: Day 930 |
173
|
10.7
|
Toxin A TNA: Day 1110 |
212
|
10.2
|
Toxin B TNA: Day 0 |
12.3
|
13.2
|
Toxin B TNA: Day 14 |
32.7
|
13.3
|
Toxin B TNA: Day 30 |
37.8
|
13.4
|
Toxin B TNA: Day 60 |
43.9
|
14.3
|
Toxin B TNA: Day 210 |
41.4
|
13.2
|
Toxin B TNA: Day 390 |
38.4
|
13.5
|
Toxin B TNA: Day 570 |
35.7
|
13.7
|
Toxin B TNA: Day 750 |
34.3
|
14.6
|
Toxin B TNA: Day 930 |
31.0
|
17.0
|
Toxin B TNA: Day 1110 |
46.8
|
14.0
|
Title | Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA |
---|---|
Description | Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations. |
Time Frame | Day 60 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with evaluable data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 436 | 220 |
Toxin A TNA: >=2 |
85.6
1.4%
|
0.5
0%
|
Toxin A TNA: >=4 |
78.2
1.3%
|
0.5
0%
|
Toxin B TNA: >=2 |
30.9
0.5%
|
2.8
0.1%
|
Toxin B TNA: >=4 |
27.4
0.4%
|
1.8
0.1%
|
Title | Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI |
---|---|
Description | Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. |
Time Frame | Day 0 and Day 60 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, 'number analyzed' = participants with available data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 34 | 16 |
Toxin A TNA: Day 0 |
12.4
|
12.0
|
Toxin A TNA: Day 60 |
176
|
10.7
|
Toxin B TNA: Day 0 |
16.7
|
11.1
|
Toxin B TNA: Day 60 |
53.0
|
13.1
|
Title | Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions |
---|---|
Description | Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: >= 25 to <=50 mm, Grade 2: >51 to <=100 mm, Grade 3: >100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: >= 38.0°C to <=38.4°C or >= 100.4° Fahrenheit (F) to <=101.1°F, Grade 2: >=38.5°C to <= 38.9°C or >=101.2°F to <=102.0°F, Grade 3: >=39.0°C or >=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain. |
Time Frame | Day 0 to Day 6 after any vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on all participants who received vaccine and were evaluable for reactogenicity. Here, 'number analyzed' = participants with available data for each specified category. |
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group |
---|---|---|
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). |
Measure Participants | 1227 | 608 |
Injection site Pain |
38.6
0.6%
|
13.5
0.4%
|
Injection site Erythema |
4.2
0.1%
|
0.0
0%
|
Injection site Swelling |
3.8
0.1%
|
0.3
0%
|
Fever |
4.8
0.1%
|
5.7
0.2%
|
Headache |
25.3
0.4%
|
22.5
0.7%
|
Malaise |
23.9
0.4%
|
19.6
0.6%
|
Myalgia |
26.6
0.4%
|
21.2
0.7%
|
Arthralgia |
19.5
0.3%
|
16.7
0.5%
|
Adverse Events
Time Frame | Adverse events data was collected throughout the study (up to 3 years). | |||
---|---|---|---|---|
Adverse Event Reporting Description | Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination. | |||
Arm/Group Title | C. Difficile Vaccine Group | Placebo Group | ||
Arm/Group Description | Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3). | ||
All Cause Mortality |
||||
C. Difficile Vaccine Group | Placebo Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 255/6113 (4.2%) | 127/3057 (4.2%) | ||
Serious Adverse Events |
||||
C. Difficile Vaccine Group | Placebo Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1662/6113 (27.2%) | 851/3057 (27.8%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 19/6113 (0.3%) | 20 | 11/3057 (0.4%) | 13 |
Antiphospholipid Syndrome | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Coagulopathy | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Haemolytic Anaemia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Haemorrhagic Anaemia | 2/6113 (0%) | 2 | 5/3057 (0.2%) | 5 |
Iron Deficiency Anaemia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Microcytic Anaemia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Nephrogenic Anaemia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Normochromic Normocytic Anaemia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Thrombocytosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardiac disorders | ||||
Acute Coronary Syndrome | 13/6113 (0.2%) | 15 | 2/3057 (0.1%) | 2 |
Acute Myocardial Infarction | 56/6113 (0.9%) | 59 | 22/3057 (0.7%) | 24 |
Angina Pectoris | 19/6113 (0.3%) | 20 | 10/3057 (0.3%) | 10 |
Angina Unstable | 27/6113 (0.4%) | 32 | 9/3057 (0.3%) | 15 |
Aortic Valve Incompetence | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Aortic Valve Stenosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Arrhythmia | 9/6113 (0.1%) | 9 | 2/3057 (0.1%) | 2 |
Arrhythmia Supraventricular | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Arteriosclerosis Coronary Artery | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Atrial Fibrillation | 42/6113 (0.7%) | 53 | 14/3057 (0.5%) | 15 |
Atrial Flutter | 3/6113 (0%) | 3 | 2/3057 (0.1%) | 2 |
Atrial Tachycardia | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Atrial Thrombosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Atrioventricular Block | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Atrioventricular Block Complete | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Bradyarrhythmia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Bradycardia | 5/6113 (0.1%) | 6 | 5/3057 (0.2%) | 5 |
Bundle Branch Block Left | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardiac Arrest | 10/6113 (0.2%) | 11 | 8/3057 (0.3%) | 8 |
Cardiac Disorder | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Cardiac Failure | 34/6113 (0.6%) | 40 | 16/3057 (0.5%) | 36 |
Cardiac Failure Acute | 16/6113 (0.3%) | 22 | 6/3057 (0.2%) | 7 |
Cardiac Failure Chronic | 3/6113 (0%) | 5 | 0/3057 (0%) | 0 |
Cardiac Failure Congestive | 69/6113 (1.1%) | 102 | 29/3057 (0.9%) | 37 |
Cardiac Tamponade | 6/6113 (0.1%) | 6 | 2/3057 (0.1%) | 2 |
Cardiac Valve Disease | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardio-Respiratory Arrest | 10/6113 (0.2%) | 11 | 3/3057 (0.1%) | 3 |
Cardiogenic Shock | 8/6113 (0.1%) | 9 | 5/3057 (0.2%) | 5 |
Cardiomyopathy | 5/6113 (0.1%) | 6 | 1/3057 (0%) | 1 |
Cardiopulmonary Failure | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardiorenal Syndrome | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cor Pulmonale | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Coronary Artery Disease | 22/6113 (0.4%) | 23 | 7/3057 (0.2%) | 7 |
Coronary Artery Occlusion | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Coronary Artery Stenosis | 7/6113 (0.1%) | 8 | 2/3057 (0.1%) | 2 |
Coronary Artery Thrombosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Heart Valve Incompetence | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Hypertensive Heart Disease | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Intracardiac Thrombus | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Ischaemic Cardiomyopathy | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Left Ventricular Failure | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mitral Valve Incompetence | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Myocardial Infarction | 27/6113 (0.4%) | 27 | 16/3057 (0.5%) | 16 |
Myocardial Ischaemia | 8/6113 (0.1%) | 8 | 3/3057 (0.1%) | 3 |
Palpitations | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pericardial Effusion | 5/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Pericarditis | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Prinzmetal Angina | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pulseless Electrical Activity | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Reperfusion Arrhythmia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Right Ventricular Failure | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Sick Sinus Syndrome | 2/6113 (0%) | 2 | 3/3057 (0.1%) | 3 |
Sinoatrial Block | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Sinus Bradycardia | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Stress Cardiomyopathy | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Supraventricular Tachyarrhythmia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Supraventricular Tachycardia | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Tachyarrhythmia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Tachycardia | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Tricuspid Valve Incompetence | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ventricle Rupture | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Ventricular Arrhythmia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ventricular Fibrillation | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Ventricular Tachycardia | 5/6113 (0.1%) | 5 | 4/3057 (0.1%) | 4 |
Congenital, familial and genetic disorders | ||||
Anophthalmos | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cardiac Septal Defect | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Ectopic Ureter | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hydrocele | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Ear and labyrinth disorders | ||||
Deafness Neurosensory | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Meniere's Disease | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Sudden Hearing Loss | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vertigo | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Vertigo Positional | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Endocrine disorders | ||||
Adrenal Insufficiency | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Goitre | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hyperparathyroidism | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hyperparathyroidism Primary | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Thyroid Mass | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Eye disorders | ||||
Amaurosis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Amaurosis Fugax | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Aphakia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cataract | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 3 |
Conjunctivochalasis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Eyelid Ptosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Glaucoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Phacolytic Glaucoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pterygium | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Retinal Detachment | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Retinal Vein Occlusion | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Vitreous Haemorrhage | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastrointestinal disorders | ||||
Abdominal Adhesions | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Abdominal Hernia | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Abdominal Pain | 14/6113 (0.2%) | 14 | 11/3057 (0.4%) | 15 |
Abdominal Pain Lower | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Abdominal Pain Upper | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Abdominal Wall Haematoma | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Anal Fissure | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Anal Fistula | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ascites | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Change Of Bowel Habit | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Colitis | 5/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Colitis Ischaemic | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Colitis Microscopic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Colonic Pseudo-Obstruction | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Colonic Stenosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Constipation | 9/6113 (0.1%) | 9 | 2/3057 (0.1%) | 2 |
Crohn's Disease | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Dental Pulp Disorder | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Diabetic Gastroparesis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Diaphragmatic Hernia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Diarrhoea | 8/6113 (0.1%) | 8 | 2/3057 (0.1%) | 2 |
Diverticular Perforation | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Diverticulum | 4/6113 (0.1%) | 5 | 1/3057 (0%) | 1 |
Duodenal Ulcer | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Duodenal Ulcer Haemorrhage | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Dyspepsia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Enterovesical Fistula | 1/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Erosive Duodenitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Erosive Oesophagitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Faecaloma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Food Poisoning | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastric Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastric Haemorrhage | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Gastric Ulcer | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Gastric Ulcer Haemorrhage | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Gastric Ulcer Perforation | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Gastritis | 8/6113 (0.1%) | 8 | 4/3057 (0.1%) | 5 |
Gastritis Erosive | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Gastritis Haemorrhagic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastroduodenal Ulcer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastrointestinal Amyloidosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Gastrointestinal Haemorrhage | 13/6113 (0.2%) | 13 | 6/3057 (0.2%) | 6 |
Gastrointestinal Hypomotility | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Gastrointestinal Obstruction | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Gastrooesophageal Reflux Disease | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Haematemesis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Haemorrhoids | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Hernial Eventration | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hiatus Hernia | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Ileal Stenosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ileus | 6/6113 (0.1%) | 6 | 2/3057 (0.1%) | 2 |
Ileus Paralytic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Impaired Gastric Emptying | 1/6113 (0%) | 5 | 0/3057 (0%) | 0 |
Inguinal Hernia | 4/6113 (0.1%) | 4 | 3/3057 (0.1%) | 3 |
Inguinal Hernia, Obstructive | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Intestinal Haemorrhage | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Intestinal Obstruction | 6/6113 (0.1%) | 7 | 1/3057 (0%) | 1 |
Intestinal Perforation | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Intra-Abdominal Haemorrhage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Large Intestinal Obstruction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Large Intestine Polyp | 5/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Lower Gastrointestinal Haemorrhage | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Melaena | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Mesenteric Artery Thrombosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 2 |
Mesenteric Vein Thrombosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Nausea | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Oesophageal Obstruction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Oesophageal Stenosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Oesophageal Varices Haemorrhage | 2/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Oesophagitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Oral Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pancreatic Pseudocyst | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pancreatitis | 6/6113 (0.1%) | 7 | 3/3057 (0.1%) | 3 |
Pancreatitis Acute | 4/6113 (0.1%) | 5 | 6/3057 (0.2%) | 6 |
Pancreatitis Chronic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pancreatitis Relapsing | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Peptic Ulcer | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Periodontal Disease | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Peritoneal Adhesions | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Peritoneal Haemorrhage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Proctalgia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rectal Haemorrhage | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Rectal Prolapse | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Small Intestinal Obstruction | 5/6113 (0.1%) | 5 | 2/3057 (0.1%) | 2 |
Spigelian Hernia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Subileus | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Thrombosis Mesenteric Vessel | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Umbilical Hernia | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Umbilical Hernia, Obstructive | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Upper Gastrointestinal Haemorrhage | 5/6113 (0.1%) | 5 | 2/3057 (0.1%) | 2 |
Varices Oesophageal | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Volvulus | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vomiting | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
General disorders | ||||
Asthenia | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Catheter Site Haemorrhage | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Chest Discomfort | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Chest Pain | 50/6113 (0.8%) | 56 | 19/3057 (0.6%) | 27 |
Death | 8/6113 (0.1%) | 8 | 6/3057 (0.2%) | 6 |
Device Dislocation | 9/6113 (0.1%) | 9 | 1/3057 (0%) | 1 |
Device Failure | 3/6113 (0%) | 3 | 2/3057 (0.1%) | 2 |
Device Issue | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Device Leakage | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Device Malfunction | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Device Occlusion | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Drug Interaction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Fatigue | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
General Physical Health Deterioration | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
General Symptom | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Generalised Oedema | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hernia Obstructive | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hyperthermia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Impaired Healing | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Implant Site Haematoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Inflammation | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Malaise | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Medical Device Complication | 7/6113 (0.1%) | 8 | 4/3057 (0.1%) | 4 |
Multi-Organ Failure | 4/6113 (0.1%) | 4 | 3/3057 (0.1%) | 3 |
Non-Cardiac Chest Pain | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Oedema | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Oedema Peripheral | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Pain | 2/6113 (0%) | 2 | 3/3057 (0.1%) | 3 |
Patient-Device Incompatibility | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Perforated Ulcer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Polyp | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Pyrexia | 5/6113 (0.1%) | 5 | 3/3057 (0.1%) | 3 |
Spinal Pain | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Stent-Graft Endoleak | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Sudden Cardiac Death | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Sudden Death | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Surgical Failure | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Systemic Inflammatory Response Syndrome | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Hepatobiliary disorders | ||||
Bile Duct Obstruction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bile Duct Stenosis | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Bile Duct Stone | 3/6113 (0%) | 3 | 3/3057 (0.1%) | 3 |
Cholangitis | 2/6113 (0%) | 2 | 3/3057 (0.1%) | 3 |
Cholangitis Acute | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cholecystitis | 7/6113 (0.1%) | 7 | 1/3057 (0%) | 1 |
Cholecystitis Acute | 2/6113 (0%) | 2 | 7/3057 (0.2%) | 7 |
Cholecystitis Chronic | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Cholelithiasis | 7/6113 (0.1%) | 7 | 6/3057 (0.2%) | 6 |
Cirrhosis Alcoholic | 2/6113 (0%) | 2 | 1/3057 (0%) | 2 |
Gallbladder Polyp | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hepatic Cirrhosis | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Hepatic Cyst | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hepatic Failure | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Hepatitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hepatitis Acute | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hepatorenal Syndrome | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hydrocholecystis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Immune system disorders | ||||
Anaphylactic Reaction | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Anaphylactic Shock | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Device Allergy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Food Allergy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Secondary Immunodeficiency | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Infections and infestations | ||||
Abdominal Hernia Gangrenous | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Abdominal Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Abdominal Sepsis | 2/6113 (0%) | 2 | 3/3057 (0.1%) | 3 |
Abdominal Wall Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Abscess | 4/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Abscess Limb | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Anal Abscess | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Appendicitis | 5/6113 (0.1%) | 5 | 2/3057 (0.1%) | 2 |
Appendicitis Perforated | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Arteriovenous Graft Site Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Arthritis Bacterial | 11/6113 (0.2%) | 11 | 3/3057 (0.1%) | 3 |
Arthritis Infective | 8/6113 (0.1%) | 9 | 3/3057 (0.1%) | 4 |
Asymptomatic Bacteriuria | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Atypical Mycobacterial Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bacteraemia | 8/6113 (0.1%) | 9 | 2/3057 (0.1%) | 2 |
Bacterial Infection | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Bacterial Sepsis | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Bacterial Tracheitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Beta Haemolytic Streptococcal Infection | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Biliary Sepsis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Breast Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Breast Cellulitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Bronchitis | 11/6113 (0.2%) | 11 | 3/3057 (0.1%) | 3 |
Bronchopneumonia | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Bursitis Infective | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Candida Sepsis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cellulitis | 63/6113 (1%) | 78 | 36/3057 (1.2%) | 41 |
Chronic Hepatitis C | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Clostridium Difficile Colitis | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Clostridium Difficile Infection | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Dengue Fever | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Dermo-Hypodermitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Device Related Infection | 18/6113 (0.3%) | 22 | 12/3057 (0.4%) | 14 |
Diabetic Foot Infection | 26/6113 (0.4%) | 30 | 9/3057 (0.3%) | 9 |
Diabetic Gangrene | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Diarrhoea Infectious | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Disseminated Tuberculosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Diverticulitis | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Empyema | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Endocarditis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Endocarditis Bacterial | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Enterobacter Pneumonia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Enterocolitis Bacterial | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Enterocolitis Infectious | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Erysipelas | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Escherichia Bacteraemia | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Escherichia Sepsis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Escherichia Urinary Tract Infection | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Gangrene | 2/6113 (0%) | 2 | 1/3057 (0%) | 3 |
Gastric Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastroenteritis | 10/6113 (0.2%) | 10 | 6/3057 (0.2%) | 6 |
Gastroenteritis Viral | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Genital Herpes | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Graft Infection | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Groin Abscess | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Haematoma Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hepatic Cyst Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Herpes Virus Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Herpes Zoster | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Implant Site Infection | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Incision Site Infection | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Infected Skin Ulcer | 2/6113 (0%) | 3 | 2/3057 (0.1%) | 2 |
Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Infection In An Immunocompromised Host | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Infective Exacerbation Of Bronchiectasis | 2/6113 (0%) | 6 | 0/3057 (0%) | 0 |
Infective Exacerbation Of Chronic Obstructive Airways Disease | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Infective Spondylitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Influenza | 5/6113 (0.1%) | 5 | 2/3057 (0.1%) | 2 |
Intervertebral Discitis | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Joint Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Kidney Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Liver Abscess | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Lobar Pneumonia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Localised Infection | 4/6113 (0.1%) | 4 | 4/3057 (0.1%) | 5 |
Lower Respiratory Tract Infection | 7/6113 (0.1%) | 7 | 2/3057 (0.1%) | 2 |
Lower Respiratory Tract Infection Viral | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lung Infection | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Mediastinitis | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Meningitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mumps | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mycobacterium Avium Complex Infection | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Nail Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Neurological Infection | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Neurosyphilis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Orchitis | 6/6113 (0.1%) | 6 | 1/3057 (0%) | 2 |
Osteomyelitis | 27/6113 (0.4%) | 29 | 11/3057 (0.4%) | 16 |
Osteomyelitis Acute | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Osteomyelitis Chronic | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Otitis Externa | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Paraspinal Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Paronychia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Perihepatic Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Perineal Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Periodontitis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Peritonitis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Peritonsillar Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pneumonia | 107/6113 (1.8%) | 122 | 67/3057 (2.2%) | 84 |
Pneumonia Bacterial | 5/6113 (0.1%) | 9 | 2/3057 (0.1%) | 2 |
Pneumonia Necrotising | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Pneumonia Pneumococcal | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Pneumonia Staphylococcal | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Poliomyelitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Post Procedural Cellulitis | 1/6113 (0%) | 1 | 1/3057 (0%) | 2 |
Post Procedural Infection | 7/6113 (0.1%) | 7 | 1/3057 (0%) | 1 |
Post Procedural Pneumonia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Post Procedural Sepsis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Postoperative Wound Infection | 28/6113 (0.5%) | 30 | 15/3057 (0.5%) | 15 |
Prostatic Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Psoas Abscess | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Pulmonary Sepsis | 1/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Pulmonary Tuberculosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Pyelonephritis | 5/6113 (0.1%) | 5 | 2/3057 (0.1%) | 2 |
Pyelonephritis Acute | 7/6113 (0.1%) | 8 | 1/3057 (0%) | 1 |
Renal Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Respiratory Tract Infection | 7/6113 (0.1%) | 8 | 4/3057 (0.1%) | 6 |
Scrotal Abscess | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Sepsis | 34/6113 (0.6%) | 38 | 18/3057 (0.6%) | 18 |
Septic Arthritis Staphylococcal | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Septic Shock | 26/6113 (0.4%) | 27 | 13/3057 (0.4%) | 13 |
Sinusitis Bacterial | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Skin Bacterial Infection | 3/6113 (0%) | 4 | 0/3057 (0%) | 0 |
Skin Infection | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Soft Tissue Infection | 3/6113 (0%) | 3 | 4/3057 (0.1%) | 4 |
Staphylococcal Bacteraemia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Staphylococcal Infection | 4/6113 (0.1%) | 4 | 3/3057 (0.1%) | 3 |
Staphylococcal Osteomyelitis | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Staphylococcal Sepsis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Subcutaneous Abscess | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Tracheitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Tracheobronchitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Tuberculosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Upper Respiratory Tract Infection | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Urinary Bladder Abscess | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Urinary Tract Infection | 91/6113 (1.5%) | 116 | 38/3057 (1.2%) | 47 |
Urinary Tract Infection Bacterial | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Urinary Tract Infection Pseudomonal | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Urosepsis | 11/6113 (0.2%) | 12 | 6/3057 (0.2%) | 6 |
Viral Infection | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Viral Upper Respiratory Tract Infection | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Wound Infection | 5/6113 (0.1%) | 5 | 1/3057 (0%) | 1 |
Wound Infection Bacterial | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Injury, poisoning and procedural complications | ||||
Abdominal Wound Dehiscence | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Accidental Overdose | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Alcohol Poisoning | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Anaemia Postoperative | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Animal Bite | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ankle Fracture | 4/6113 (0.1%) | 4 | 4/3057 (0.1%) | 4 |
Arterial Injury | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bladder Injury | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bone Fissure | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cardiac Procedure Complication | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cervical Vertebral Fracture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Chemical Poisoning | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Concussion | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Contusion | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Coronary Artery Restenosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Craniocerebral Injury | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Dislocation Of Vertebra | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Dural Tear | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Exposure To Toxic Agent | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Extradural Haematoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Facial Bones Fracture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Fall | 17/6113 (0.3%) | 18 | 7/3057 (0.2%) | 7 |
Fat Embolism | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Femoral Neck Fracture | 5/6113 (0.1%) | 5 | 2/3057 (0.1%) | 2 |
Femur Fracture | 11/6113 (0.2%) | 12 | 4/3057 (0.1%) | 4 |
Foot Fracture | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Forearm Fracture | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Head Injury | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Heat Exhaustion | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Heat Stroke | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hip Fracture | 8/6113 (0.1%) | 8 | 6/3057 (0.2%) | 7 |
Humerus Fracture | 4/6113 (0.1%) | 4 | 1/3057 (0%) | 1 |
Incisional Hernia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Joint Dislocation | 12/6113 (0.2%) | 16 | 0/3057 (0%) | 0 |
Joint Dislocation Postoperative | 4/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Joint Injury | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Laceration | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ligament Injury | 2/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Ligament Rupture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ligament Sprain | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Limb Injury | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lower Limb Fracture | 3/6113 (0%) | 3 | 2/3057 (0.1%) | 2 |
Mechanical Ventilation Complication | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Meniscus Injury | 0/6113 (0%) | 0 | 5/3057 (0.2%) | 6 |
Multiple Fractures | 0/6113 (0%) | 0 | 3/3057 (0.1%) | 3 |
Multiple Injuries | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Muscle Rupture | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Muscle Strain | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Overdose | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Patella Fracture | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Pelvic Fracture | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Periprosthetic Fracture | 6/6113 (0.1%) | 7 | 5/3057 (0.2%) | 6 |
Pneumothorax Traumatic | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Post Concussion Syndrome | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Post Procedural Complication | 18/6113 (0.3%) | 18 | 11/3057 (0.4%) | 13 |
Post Procedural Discharge | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Post Procedural Haematoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Post Procedural Haematuria | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Post Procedural Haemorrhage | 3/6113 (0%) | 3 | 3/3057 (0.1%) | 3 |
Post Procedural Swelling | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Postoperative Fever | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Postoperative Ileus | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Postoperative Respiratory Failure | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Postoperative Thoracic Procedure Complication | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Postoperative Wound Complication | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Procedural Haemorrhage | 4/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Procedural Hypotension | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Procedural Nausea | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Procedural Pain | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Pubis Fracture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Radius Fracture | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Rectal Laceration Postoperative | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Renal Haematoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rib Fracture | 2/6113 (0%) | 2 | 3/3057 (0.1%) | 3 |
Road Traffic Accident | 2/6113 (0%) | 2 | 5/3057 (0.2%) | 5 |
Scrotal Haematoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Seroma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Skin Injury | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Spinal Compression Fracture | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Spinal Fracture | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Stab Wound | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Stress Fracture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Subdural Haematoma | 6/6113 (0.1%) | 6 | 3/3057 (0.1%) | 3 |
Subdural Haemorrhage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Tendon Rupture | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Thermal Burn | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Thoracic Vertebral Fracture | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Tibia Fracture | 4/6113 (0.1%) | 4 | 1/3057 (0%) | 1 |
Toxicity To Various Agents | 4/6113 (0.1%) | 4 | 1/3057 (0%) | 1 |
Tracheostomy Malfunction | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Traumatic Arthritis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Traumatic Intracranial Haemorrhage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Upper Limb Fracture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Urethral Injury | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Urethral Stricture Postoperative | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Vascular Bypass Dysfunction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Vascular Graft Occlusion | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Vascular Graft Thrombosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Vascular Pseudoaneurysm | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Wound | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Wound Dehiscence | 3/6113 (0%) | 5 | 2/3057 (0.1%) | 2 |
Wrist Fracture | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Investigations | ||||
Anticoagulation Drug Level Above Therapeutic | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Aspiration Bronchial | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Blood Creatinine Increased | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Blood Potassium Decreased | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Carbon Dioxide Abnormal | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardiac Pacemaker Evaluation | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Coagulation Time Prolonged | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Electrocardiogram St Segment Elevation | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Influenza A Virus Test Positive | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
International Normalised Ratio Increased | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Oxygen Saturation Decreased | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Prothrombin Time Abnormal | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Transaminases Increased | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Urine Output Decreased | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Cachexia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Central Obesity | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Decreased Appetite | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Dehydration | 5/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Diabetes Mellitus | 12/6113 (0.2%) | 15 | 2/3057 (0.1%) | 2 |
Diabetes Mellitus Inadequate Control | 8/6113 (0.1%) | 11 | 2/3057 (0.1%) | 2 |
Diabetic Complication | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Diabetic Ketoacidosis | 3/6113 (0%) | 4 | 2/3057 (0.1%) | 2 |
Electrolyte Imbalance | 2/6113 (0%) | 2 | 3/3057 (0.1%) | 3 |
Fluid Overload | 4/6113 (0.1%) | 6 | 5/3057 (0.2%) | 13 |
Gout | 5/6113 (0.1%) | 6 | 0/3057 (0%) | 0 |
Hyperamylasaemia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hypercalcaemia | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Hyperglycaemia | 10/6113 (0.2%) | 12 | 6/3057 (0.2%) | 6 |
Hyperglycaemic Hyperosmolar Nonketotic Syndrome | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Hyperkalaemia | 5/6113 (0.1%) | 6 | 4/3057 (0.1%) | 4 |
Hyperuricaemia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hypervolaemia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hypoglycaemia | 11/6113 (0.2%) | 11 | 6/3057 (0.2%) | 7 |
Hypokalaemia | 2/6113 (0%) | 2 | 1/3057 (0%) | 2 |
Hyponatraemia | 6/6113 (0.1%) | 6 | 1/3057 (0%) | 1 |
Hypovolaemia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Malnutrition | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Metabolic Acidosis | 0/6113 (0%) | 0 | 3/3057 (0.1%) | 3 |
Obesity | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Type 1 Diabetes Mellitus | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Type 2 Diabetes Mellitus | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Musculoskeletal and connective tissue disorders | ||||
Ankylosing Spondylitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Arthralgia | 10/6113 (0.2%) | 10 | 4/3057 (0.1%) | 4 |
Arthritis | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Arthrofibrosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Arthropathy | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Back Pain | 8/6113 (0.1%) | 9 | 8/3057 (0.3%) | 10 |
Bursitis | 3/6113 (0%) | 3 | 2/3057 (0.1%) | 2 |
Cervical Spinal Stenosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Chondropathy | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Chronic Recurrent Multifocal Osteomyelitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Collagen Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Costochondritis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Exostosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Fistula | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Foot Deformity | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Fracture Nonunion | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Gouty Arthritis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Intervertebral Disc Degeneration | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Intervertebral Disc Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Intervertebral Disc Protrusion | 4/6113 (0.1%) | 4 | 3/3057 (0.1%) | 3 |
Joint Instability | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Joint Swelling | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lumbar Spinal Stenosis | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Mobility Decreased | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Muscle Necrosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Muscle Spasms | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Musculoskeletal Chest Pain | 5/6113 (0.1%) | 5 | 1/3057 (0%) | 1 |
Musculoskeletal Pain | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Myalgia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Neck Pain | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Osteitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Osteoarthritis | 47/6113 (0.8%) | 51 | 19/3057 (0.6%) | 19 |
Pain In Extremity | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Pseudarthrosis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Psoriatic Arthropathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rhabdomyolysis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Rotator Cuff Syndrome | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 3 |
Scoliosis | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Spinal Column Stenosis | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Spinal Osteoarthritis | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Spondylitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Spondylolisthesis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Tendonitis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Tenosynovitis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Abdominal Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Adenocarcinoma | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Adenocarcinoma Gastric | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Adenocarcinoma Of Colon | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Adenocarcinoma Pancreas | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Adrenal Adenoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Basal Cell Carcinoma | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Benign Bone Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bladder Cancer | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Bladder Neoplasm | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Bladder Transitional Cell Carcinoma Recurrent | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bladder Transitional Cell Carcinoma Stage Ii | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Bone Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Brain Cancer Metastatic | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Brain Neoplasm | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Brain Neoplasm Malignant | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Breast Cancer | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Breast Cancer Metastatic | 0/6113 (0%) | 0 | 1/3057 (0%) | 2 |
Breast Cancer Stage Ii | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Breast Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bronchial Carcinoma | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Burkitt's Lymphoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Carcinoid Tumour Of The Duodenum | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cervix Carcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cervix Carcinoma Recurrent | 1/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Cervix Carcinoma Stage I | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Chronic Lymphocytic Leukaemia | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Clear Cell Renal Cell Carcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Colon Adenoma | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Colon Cancer | 2/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Colon Neoplasm | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Diffuse Large B-Cell Lymphoma | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Endometrial Adenocarcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Endometrial Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Eyelid Tumour | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gallbladder Adenocarcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Gastric Adenoma | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Gastric Neoplasm | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Gastrointestinal Carcinoma | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Gastrointestinal Neoplasm | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Gastrointestinal Stromal Tumour | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Glioblastoma Multiforme | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hepatic Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hepatocellular Carcinoma | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Intraductal Papillary Mucinous Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Kaposi's Sarcoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Leiomyosarcoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Leukaemia | 1/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Lipoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lung Adenocarcinoma | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Lung Cancer Metastatic | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Lung Carcinoma Cell Type Unspecified Recurrent | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lung Carcinoma Cell Type Unspecified Stage Iv | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Lung Neoplasm | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Lung Neoplasm Malignant | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Lymphoma | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Malignant Melanoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Malignant Neoplasm Of Eye | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Malignant Neoplasm Of Renal Pelvis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Malignant Pleural Effusion | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Malignant Respiratory Tract Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mantle Cell Lymphoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mediastinum Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Meningioma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mesothelioma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Metastases To Central Nervous System | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Metastases To Lung | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Metastatic Carcinoma Of The Bladder | 2/6113 (0%) | 4 | 0/3057 (0%) | 0 |
Metastatic Neoplasm | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Neoplasm Malignant | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Neoplasm Of Thymus | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Neoplasm Prostate | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Neuroendocrine Tumour | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Nodal Marginal Zone B-Cell Lymphoma | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Non-Small Cell Lung Cancer | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Non-Small Cell Lung Cancer Recurrent | 1/6113 (0%) | 4 | 0/3057 (0%) | 0 |
Oesophageal Carcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ovarian Cancer | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Ovarian Epithelial Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pancreatic Carcinoma | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Pancreatic Carcinoma Metastatic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pancreatic Neuroendocrine Tumour | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Papillary Thyroid Cancer | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Parathyroid Tumour Benign | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Plasma Cell Myeloma | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Prostate Cancer | 17/6113 (0.3%) | 17 | 3/3057 (0.1%) | 3 |
Prostate Cancer Metastatic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rectal Adenocarcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rectal Cancer | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Renal Cell Carcinoma | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Renal Neoplasm | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Retroperitoneal Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Salivary Gland Adenoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Salivary Gland Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Small Cell Lung Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Small Intestine Carcinoma | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Squamous Cell Carcinoma | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Superficial Spreading Melanoma Stage Unspecified | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Testicular Neoplasm | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Transitional Cell Carcinoma | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Uterine Cancer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Nervous system disorders | ||||
Altered State Of Consciousness | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Apallic Syndrome | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Arachnoid Cyst | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Ataxia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Brain Stem Stroke | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Carotid Arteriosclerosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Carotid Artery Stenosis | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Carpal Tunnel Syndrome | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Cerebral Artery Stenosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cerebral Haemorrhage | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Cerebral Infarction | 5/6113 (0.1%) | 5 | 7/3057 (0.2%) | 7 |
Cerebral Ischaemia | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Cerebral Thrombosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cerebrovascular Accident | 19/6113 (0.3%) | 20 | 8/3057 (0.3%) | 8 |
Cerebrovascular Disorder | 3/6113 (0%) | 3 | 3/3057 (0.1%) | 3 |
Cervical Myelopathy | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cervicobrachial Syndrome | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Chronic Inflammatory Demyelinating Polyradiculoneuropathy | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Convulsion | 11/6113 (0.2%) | 15 | 9/3057 (0.3%) | 22 |
Critical Illness Polyneuropathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Dementia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Dementia Alzheimer's Type | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Dementia With Lewy Bodies | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Diabetic Neuropathy | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 3 |
Dizziness | 4/6113 (0.1%) | 4 | 4/3057 (0.1%) | 4 |
Dizziness Postural | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Embolic Stroke | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Encephalopathy | 5/6113 (0.1%) | 5 | 4/3057 (0.1%) | 4 |
Epilepsy | 2/6113 (0%) | 3 | 1/3057 (0%) | 3 |
Facial Paresis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Haemorrhage Intracranial | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Haemorrhagic Stroke | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Headache | 3/6113 (0%) | 3 | 2/3057 (0.1%) | 2 |
Hemiplegic Migraine | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hepatic Encephalopathy | 2/6113 (0%) | 6 | 4/3057 (0.1%) | 7 |
Hydrocephalus | 1/6113 (0%) | 1 | 1/3057 (0%) | 2 |
Hypertensive Encephalopathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hypoaesthesia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hypoglycaemic Encephalopathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hypoxic-Ischaemic Encephalopathy | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Intercostal Neuralgia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Intracranial Aneurysm | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Intracranial Pressure Increased | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ischaemic Cerebral Infarction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ischaemic Stroke | 11/6113 (0.2%) | 13 | 5/3057 (0.2%) | 5 |
Lacunar Infarction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lumbar Radiculopathy | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Metabolic Encephalopathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Migraine | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Neuropathy Peripheral | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Normal Pressure Hydrocephalus | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Paraesthesia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Partial Seizures | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Pneumocephalus | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Polyneuropathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Post-Traumatic Headache | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Presyncope | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Radicular Pain | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Radicular Syndrome | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Spinal Cord Compression | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Status Epilepticus | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Subarachnoid Haemorrhage | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Syncope | 14/6113 (0.2%) | 15 | 9/3057 (0.3%) | 9 |
Tension Headache | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Thalamus Haemorrhage | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Toxic Encephalopathy | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Transient Global Amnesia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Transient Ischaemic Attack | 21/6113 (0.3%) | 21 | 8/3057 (0.3%) | 8 |
Tremor | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Trigeminal Neuralgia | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vertebrobasilar Insufficiency | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vertigo Cns Origin | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vocal Cord Paralysis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Psychiatric disorders | ||||
Alcohol Abuse | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Alcohol Withdrawal Syndrome | 2/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Completed Suicide | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Conversion Disorder | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Delirium | 2/6113 (0%) | 2 | 4/3057 (0.1%) | 4 |
Depression | 4/6113 (0.1%) | 5 | 1/3057 (0%) | 1 |
Drug Dependence | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Impaired Self-Care | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Major Depression | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Mental Disorder | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Mental Status Changes | 4/6113 (0.1%) | 4 | 5/3057 (0.2%) | 5 |
Panic Attack | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Psychotic Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Schizoaffective Disorder | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Schizophrenia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Suicidal Ideation | 0/6113 (0%) | 0 | 3/3057 (0.1%) | 3 |
Suicide Attempt | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Renal and urinary disorders | ||||
Azotaemia | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Bladder Mass | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bladder Neck Obstruction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Bladder Outlet Obstruction | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Calculus Ureteric | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 3 |
Calculus Urinary | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Cystitis Interstitial | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Diabetic Nephropathy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Haematuria | 8/6113 (0.1%) | 8 | 6/3057 (0.2%) | 7 |
Hydronephrosis | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Lupus Nephritis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Micturition Disorder | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Nephrolithiasis | 9/6113 (0.1%) | 10 | 1/3057 (0%) | 2 |
Nephrotic Syndrome | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Obstructive Uropathy | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Proteinuria | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Renal Failure | 7/6113 (0.1%) | 8 | 3/3057 (0.1%) | 3 |
Renal Failure Acute | 31/6113 (0.5%) | 35 | 8/3057 (0.3%) | 9 |
Renal Failure Chronic | 17/6113 (0.3%) | 19 | 3/3057 (0.1%) | 3 |
Renal Haemorrhage | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Renal Impairment | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Renal Injury | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Renal Tubular Necrosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Strangury | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Stress Urinary Incontinence | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Tubulointerstitial Nephritis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ureteric Stenosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Urethral Stenosis | 7/6113 (0.1%) | 8 | 6/3057 (0.2%) | 9 |
Urinary Incontinence | 3/6113 (0%) | 5 | 1/3057 (0%) | 1 |
Urinary Retention | 5/6113 (0.1%) | 8 | 2/3057 (0.1%) | 2 |
Urinoma | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vesicocutaneous Fistula | 0/6113 (0%) | 0 | 1/3057 (0%) | 2 |
Reproductive system and breast disorders | ||||
Benign Prostatic Hyperplasia | 8/6113 (0.1%) | 8 | 5/3057 (0.2%) | 5 |
Breast Enlargement | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Epididymitis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Female Genital Tract Fistula | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Genital Prolapse | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Ovarian Cyst | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Postmenopausal Haemorrhage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Prostatitis | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Prostatomegaly | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Uterine Haemorrhage | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Vaginal Haemorrhage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Vaginal Prolapse | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Acute Pulmonary Oedema | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Acute Respiratory Distress Syndrome | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Acute Respiratory Failure | 23/6113 (0.4%) | 29 | 10/3057 (0.3%) | 12 |
Alveolitis Allergic | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Apnoea | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Aspiration | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Asthma | 18/6113 (0.3%) | 23 | 3/3057 (0.1%) | 4 |
Atelectasis | 3/6113 (0%) | 3 | 1/3057 (0%) | 1 |
Bronchiectasis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Bronchitis Chronic | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Bronchospasm | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Chronic Obstructive Pulmonary Disease | 84/6113 (1.4%) | 121 | 51/3057 (1.7%) | 71 |
Chronic Respiratory Failure | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Dyspnoea | 12/6113 (0.2%) | 15 | 15/3057 (0.5%) | 15 |
Dyspnoea Exertional | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Emphysema | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Epistaxis | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 5 |
Haemoptysis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Hydropneumothorax | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hypoxia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Idiopathic Pulmonary Fibrosis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Interstitial Lung Disease | 6/6113 (0.1%) | 8 | 1/3057 (0%) | 1 |
Lung Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Lung Hernia | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Mediastinal Disorder | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Mediastinal Haemorrhage | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Obstructive Airways Disorder | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pleural Effusion | 21/6113 (0.3%) | 22 | 10/3057 (0.3%) | 11 |
Pleuritic Pain | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Pneumonia Aspiration | 4/6113 (0.1%) | 4 | 3/3057 (0.1%) | 5 |
Pneumonitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pneumothorax | 5/6113 (0.1%) | 6 | 1/3057 (0%) | 1 |
Pulmonary Congestion | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Pulmonary Embolism | 23/6113 (0.4%) | 23 | 17/3057 (0.6%) | 17 |
Pulmonary Fibrosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pulmonary Hypertension | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Pulmonary Microemboli | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Pulmonary Oedema | 6/6113 (0.1%) | 6 | 3/3057 (0.1%) | 3 |
Respiratory Acidosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Respiratory Arrest | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Respiratory Disorder | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Respiratory Distress | 3/6113 (0%) | 4 | 0/3057 (0%) | 0 |
Respiratory Failure | 16/6113 (0.3%) | 18 | 12/3057 (0.4%) | 15 |
Sinus Polyp | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Sleep Apnoea Syndrome | 4/6113 (0.1%) | 5 | 3/3057 (0.1%) | 3 |
Status Asthmaticus | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Tracheal Stenosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 3 |
Skin and subcutaneous tissue disorders | ||||
Angioedema | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Decubitus Ulcer | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Dermatitis Contact | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Diabetic Foot | 24/6113 (0.4%) | 25 | 13/3057 (0.4%) | 14 |
Diabetic Ulcer | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Ecchymosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Eczema | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Hidradenitis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Rash | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rash Erythematous | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Skin Necrosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Skin Ulcer | 11/6113 (0.2%) | 12 | 7/3057 (0.2%) | 9 |
Stevens-Johnson Syndrome | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Surgical and medical procedures | ||||
Artificial Urinary Sphincter Implant | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardiac Pacemaker Battery Replacement | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Cardioversion | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Cerebrospinal Fluid Drainage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Hip Arthroplasty | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Incisional Drainage | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Knee Arthroplasty | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Knee Operation | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Leg Amputation | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Metatarsal Excision | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Parathyroidectomy | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Rehabilitation Therapy | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Tooth Extraction | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Vascular disorders | ||||
Aneurysm | 0/6113 (0%) | 0 | 1/3057 (0%) | 2 |
Aneurysm Ruptured | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Aortic Aneurysm | 1/6113 (0%) | 1 | 3/3057 (0.1%) | 3 |
Aortic Aneurysm Rupture | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Aortic Stenosis | 2/6113 (0%) | 2 | 2/3057 (0.1%) | 2 |
Aortic Thrombosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Arterial Occlusive Disease | 2/6113 (0%) | 2 | 1/3057 (0%) | 1 |
Arterial Stenosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Arteriosclerosis | 4/6113 (0.1%) | 4 | 0/3057 (0%) | 0 |
Circulatory Collapse | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Deep Vein Thrombosis | 12/6113 (0.2%) | 12 | 5/3057 (0.2%) | 5 |
Essential Hypertension | 0/6113 (0%) | 0 | 2/3057 (0.1%) | 2 |
Extremity Necrosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Femoral Artery Occlusion | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Haematoma | 4/6113 (0.1%) | 4 | 2/3057 (0.1%) | 2 |
Hypertension | 7/6113 (0.1%) | 7 | 2/3057 (0.1%) | 2 |
Hypertensive Crisis | 9/6113 (0.1%) | 9 | 1/3057 (0%) | 1 |
Hypertensive Emergency | 3/6113 (0%) | 3 | 0/3057 (0%) | 0 |
Hypotension | 2/6113 (0%) | 2 | 5/3057 (0.2%) | 5 |
Hypovolaemic Shock | 4/6113 (0.1%) | 4 | 4/3057 (0.1%) | 4 |
Infarction | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Intra-Abdominal Haematoma | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Lymphoedema | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Orthostatic Hypotension | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Peripheral Arterial Occlusive Disease | 7/6113 (0.1%) | 8 | 4/3057 (0.1%) | 4 |
Peripheral Artery Aneurysm | 0/6113 (0%) | 0 | 1/3057 (0%) | 2 |
Peripheral Artery Stenosis | 4/6113 (0.1%) | 5 | 0/3057 (0%) | 0 |
Peripheral Artery Thrombosis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Peripheral Embolism | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Peripheral Ischaemia | 11/6113 (0.2%) | 15 | 1/3057 (0%) | 1 |
Peripheral Vascular Disorder | 12/6113 (0.2%) | 13 | 1/3057 (0%) | 1 |
Phlebitis | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Phlebitis Deep | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Post Thrombotic Syndrome | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Shock | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Shock Haemorrhagic | 5/6113 (0.1%) | 5 | 1/3057 (0%) | 1 |
Subclavian Artery Stenosis | 0/6113 (0%) | 0 | 1/3057 (0%) | 1 |
Temporal Arteritis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Thromboangiitis Obliterans | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Thrombophlebitis Superficial | 1/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Varicophlebitis | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Varicose Ulceration | 1/6113 (0%) | 1 | 2/3057 (0.1%) | 2 |
Vascular Insufficiency | 1/6113 (0%) | 1 | 0/3057 (0%) | 0 |
Venous Thrombosis | 2/6113 (0%) | 2 | 0/3057 (0%) | 0 |
Venous Thrombosis Limb | 1/6113 (0%) | 1 | 1/3057 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
C. Difficile Vaccine Group | Placebo Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1347/6113 (22%) | 401/3057 (13.1%) | ||
General disorders | ||||
Injection Site Pain | 855/6113 (14%) | 1252 | 127/3057 (4.2%) | 157 |
Malaise | 325/6113 (5.3%) | 456 | 135/3057 (4.4%) | 195 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 345/6113 (5.6%) | 481 | 146/3057 (4.8%) | 205 |
Myalgia | 368/6113 (6%) | 556 | 132/3057 (4.3%) | 201 |
Nervous system disorders | ||||
Headache | 531/6113 (8.7%) | 758 | 229/3057 (7.5%) | 327 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title | Medical Director |
---|---|
Organization | Sanofi Pasteur |
Phone | 800-633-1610 ext 1# |
Contact-US@sanofi.com |
- H-030-014
- 2013-000775-32
- U1111-1127-7162