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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_523 | Other Identifier | Merck |
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This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V710 60 µg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V710 | Biological | 0.5-mL single injection of V710 (60 µg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection | Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound. | Up to 90 days after surgery |
| Incidence Rate of Vaccine-related Serious Adverse Experiences | Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention. | Up to 360 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Invasive Staphylococcus Aureus Infection | Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection. | Up to 90 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23549582 | Derived | Fowler VG, Allen KB, Moreira ED, Moustafa M, Isgro F, Boucher HW, Corey GR, Carmeli Y, Betts R, Hartzel JS, Chan IS, McNeely TB, Kartsonis NA, Guris D, Onorato MT, Smugar SS, DiNubile MJ, Sobanjo-ter Meulen A. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial. JAMA. 2013 Apr 3;309(13):1368-78. doi: 10.1001/jama.2013.3010. |
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| ID | Title | Description |
|---|---|---|
| FG000 | V710 60 µg | V710: 0.5-ml single injection of V710 (60 µg) |
| FG001 | Placebo | Placebo : 0.5-ml single injection of matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | V710 60 µg | V710: 0.5-ml single injection of V710 (60 µg) |
| BG001 | Placebo | Placebo : 0.5-ml single injection of matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection | Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound. | The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination | Posted | Number | participants | Up to 90 days after surgery |
|
All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination
The population analyzed was all vaccinated participants with follow-up results
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V710 (60 µg) Lyophilized | V710: 0.5-ml single injection of V710 (60 µg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D016470 | Bacteremia |
| D008480 | Mediastinitis |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C579630 | V710 vaccine |
Not provided
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| Placebo | Biological | 0.5-mL single injection of matching placebo |
|
| Number of Participants With Surgical-site Staphylococcus Aureus Infection | Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed. | Up to 90 days after surgery |
| Physician Decision |
|
| Progressive disease |
|
| Protocol Violation |
|
| Study terminated by sponsor |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
V710: 0.5-ml single injection of V710 (60 µg) |
| OG001 | Placebo | Placebo : 0.5-ml single injection of matching placebo |
|
|
|
| Primary | Incidence Rate of Vaccine-related Serious Adverse Experiences | Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention. | The population analyzed included all vaccinated participants with follow-up results | Posted | Number | Events per 100 person-years | Up to 360 days after surgery |
|
|
|
|
| Secondary | Number of Participants With Invasive Staphylococcus Aureus Infection | Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection. | The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination | Posted | Number | participants | Up to 90 days after surgery |
|
|
|
|
| Secondary | Number of Participants With Surgical-site Staphylococcus Aureus Infection | Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed. | The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination | Posted | Number | participants | Up to 90 days after surgery |
|
|
|
|
| 291 |
| 3,958 |
| 749 |
| 3,958 |
| EG001 | Placebo | Placebo : 0.5-ml single injection of matching placebo | 274 | 3,967 | 343 | 3,967 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac valve disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac ventricular disorder | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Low cardiac output syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericardial haemorrhage | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricle rupture | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular dysfunction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral arteriovenous malformation haemorrhagic | Congenital, familial and genetic disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device leakage | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Candida sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Endocarditis pseudomonal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Endocarditis staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Fungal endocarditis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Mediastinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Prostatic abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pyonephrosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal mediastinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Wound infection bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac valve replacement complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Intraoperative cerebral artery occlusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Vasoplegia syndrome | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac output decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Troponin T increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bone fistula | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Basal ganglia infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness exertional | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aneurysm ruptured | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic rupture | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |