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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-US-GHCQ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse "real world" population than studied in clinical trials
Subjects will be followed through a course of FORTEO therapy for up to 24 months and for an additional 24 months after FORTEO treatment is stopped. Subjects may participate in this study for up to 48 months. All aspects of patient care, including diagnostic and therapeutic interventions, will be chosen and conducted at the discretion of the participating study physician according to their clinical judgment and the local standard of medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FORTEO (teriparatide)-treated | FORTEO-treated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FORTEO | Drug | prescribed in accordance with usual clinical practice for up to 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Non-Vertebral Fragility Fractures | Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Vertebral Fractures | Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Community sample
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lakewood | Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | FORTEO (Teriparatide)-Treated | FORTEO: prescribed in accordance with usual clinical practice for up to 24 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FORTEO (Teriparatide)-Treated | FORTEO: prescribed in accordance with usual clinical practice for up to 24 months |
| 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 | Percentage of Participants With Non-Vertebral Fragility Fractures | Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100. | Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. | Posted | Number | Percentage of participants | up to 24 months |
|
Not provided
Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
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 | FORTEO (Teriparatide)-Treated | FORTEO: prescribed in accordance with usual clinical practice for up to 24 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
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| up to 24 months |
| Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%. | Baseline, Month 24 |
| Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%. | Baseline, Month 24 |
| Treatment Adherence | Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study. | up to 24 months |
| Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²). | Baseline, up to month 24 |
| Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | BMC is an estimate of the amount of mineral (such as calcium) in the bone. | Baseline, up to month 24 |
| Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Bone area is a defined region of interest of bone. | Baseline, up to month 24 |
| Physician Criteria for Initiating FORTEO Therapy | Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here. | Baseline |
| United States |
| Physician Decision |
|
| Serious adverse event |
|
| Sponsor decision |
|
| Withdrawal by Subject |
|
| Other |
|
| Didn't take study drug |
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Physician Criteria for Initiating FORTEO Therapy | Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. The number of total participants analyzed is 4073. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants With Clinical Vertebral Fractures | Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100. | Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. | Posted | Number | Percentage of participants | up to 24 months |
|
|
|
|
| Secondary | Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%. | Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement. | Posted | Mean | Standard Error | percentage change of pain score | Baseline, Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%. | Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement. | Posted | Mean | Standard Error | percentage change of pain score | Baseline, Month 24 |
|
|
|
|
| Secondary | Treatment Adherence | Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study. | Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. | Posted | Mean | Standard Deviation | days | up to 24 months |
|
|
|
| Secondary | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²). | Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward. | Posted | Mean | Standard Error | percentage (%) change of BMD | Baseline, up to month 24 |
|
|
|
| Secondary | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | BMC is an estimate of the amount of mineral (such as calcium) in the bone. | Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward. | Posted | Mean | Standard Error | percentage (%) change of grams (g) | Baseline, up to month 24 |
|
|
|
| Secondary | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Bone area is a defined region of interest of bone. | Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward. | Posted | Mean | Standard Error | percent change of centimeter square | Baseline, up to month 24 |
|
|
|
| Secondary | Physician Criteria for Initiating FORTEO Therapy | Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here. | Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics. | Posted | Number | participants | Baseline |
|
|
| 432 |
| 4,085 |
| 0 |
| 0 |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spleen disorder | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombocytopenia | 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 |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arteriospasm coronary | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery perforation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Femoral hernia, obstructive | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal strangulation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastric infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia haemophilus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pyelonephritis acute | 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 |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Small intestine gangrene | 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 |
|
| Streptococcal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Bone scan abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Light chain analysis increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemochromatosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteitis deformans | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| B-cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Blast cell crisis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer stage IV | 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 |
|
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Leiomyosarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | 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 |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Thymoma | 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 |
|
| Amnesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Radicular pain | 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 |
|
| Agitation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal amyloidosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary 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 |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Adenomyosis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchial disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchospasm | 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 |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary eosinophilia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Colectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Superior mesenteric artery syndrome | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| 18 to 24 months (n=2266) |
|
| 0.0412 |
Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate. |
| 95 |
| No |
| Superiority or Other |
| One-sample binomial proportion test | 0.0631 | Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate. | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 18 to 24 months (n=2299) |
|
| Title | Measurements |
|---|---|
|
| Lumbar spine vertebrae numbered 1 through 4(L1-L4) |
|
| Total Hip |
|
| Trochanter |
|
| Wards Triangle |
|
| Title | Measurements |
|---|---|
|
| L1-L4 |
|
| Total Hip |
|
| Trochanter |
|
| Wards Triangle |
|
| Title | Measurements |
|---|---|
|
| L1-L4 |
|
| Total Hip |
|
| Trochanter |
|
| Wards Triangle |
|