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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_551 |
Not provided
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This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zostavax™ | Experimental | Participants randomized to receive Zoster Vaccine, Live (Zostavax™). |
|
| Placebo | Placebo Comparator | Participants randomized to receive Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine, Live (Zostavax™) | Biological | A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group | Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group | VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population. | 6 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24823623 | Derived | Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13. | |
| 23908486 |
Not provided
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Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Zostavax™ | Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). |
| FG001 | Placebo | Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zostavax™ | Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). |
| BG001 | Placebo | Participants randomized to receive a single 0.65 ml subcutaneous injection of 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 | Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group | Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population. | Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned. | Posted | Mean | 95% Confidence Interval | number of HZ cases/1000 person-years | 2 Years |
|
Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination.
AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zostavax™ | Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Late Stage Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Comparator: Placebo | Biological | A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1. |
|
| Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period |
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. |
| Through 42 days post-vaccination |
| Levin MJ, Schmader KE, Gnann JW, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Varicella-zoster virus-specific antibody responses in 50-59-year-old recipients of zoster vaccine. J Infect Dis. 2013 Nov 1;208(9):1386-90. doi: 10.1093/infdis/jit342. Epub 2013 Aug 1. |
| 22291101 | Derived | Schmader KE, Levin MJ, Gnann JW Jr, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis. 2012 Apr;54(7):922-8. doi: 10.1093/cid/cir970. Epub 2012 Jan 30. |
| Other protocol specified criteria |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo. |
|
|
|
| Secondary | Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group | VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population. | Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded. | Posted | Mean | 95% Confidence Interval | gpELISA units/mL | 6 Weeks |
|
|
|
|
| Secondary | Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period | A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. | All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up. | Posted | Number | participants | Through 42 days post-vaccination |
|
|
|
|
| 243 |
| 11,094 |
| 7,228 |
| 11,094 |
| EG001 | Placebo | Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo. | 233 | 11,116 | 2,183 | 11,116 |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mitral valve prolapse | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital diaphragmatic hernia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Porphyria acute | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatic disorder | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Perforation bile duct | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Allergic oedema | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Bursitis infective staphylococcal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Endocarditis bacterial | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Epidemic nephropathy | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pharyngeal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Bladder injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Device failure | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Ureteric injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Benign neoplasm of cervix uteri | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Borderline ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Endometrial cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Fallopian tube cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Nasal cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Waldenstrom's macroglobulinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cervical root pain | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute psychosis | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depression suicidal | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Drug dependence | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Suicidal behaviour | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Laryngeal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
Not provided
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |