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The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zoledronic acid | Active Comparator | denosumab placebo with active zoledronic acid |
|
| denosumab | Experimental | active denosumab with zoledronic acid placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Biological | 120 milligrams by subcutaneous injection every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First On-Study Skeletal-Related Event (Non-Inferiority) | Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method. | up to 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First On-Study Skeletal-Related Event (Superiority) | Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method. | up to 33 months |
| Time to the First-and-Subsequent On-Study Skeletal-Related Event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24162260 | Background | Henry D, Vadhan-Raj S, Hirsh V, von Moos R, Hungria V, Costa L, Woll PJ, Scagliotti G, Smith G, Feng A, Jun S, Dansey R, Yeh H. Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors. Support Care Cancer. 2014 Mar;22(3):679-87. doi: 10.1007/s00520-013-2022-1. Epub 2013 Oct 26. | |
| 21343556 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
A total of 1779 participants were enrolled in the study. Three participants from one site were excluded from all analyses because Institutional Review Board (IRB) review activities and oversight were not ensured.
Participants were enrolled from 21 June 2006 through 16 May 2008
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid | Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks |
| FG001 | Denosumab | Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid | Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks |
| BG001 | Denosumab | Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks |
| 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 | Time to the First On-Study Skeletal-Related Event (Non-Inferiority) | Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method. | Full Analysis Set, composed of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | up to 33 months |
|
up to 2 years 9 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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 | Zoledronic Acid 4 mg Q4W |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| D013117 | Spinal Cord Compression |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zoledronic Acid |
| Drug |
4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks |
|
|
Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events. |
| up to 33 months |
| Background |
| Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. doi: 10.1200/JCO.2010.31.3304. Epub 2011 Feb 22. |
| 23154554 | Background | Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, Solal-Celigny P, Rodriguez G, Krzakowski M, Mehta ND, Lipton L, Garcia-Saenz JA, Pereira JR, Prabhash K, Ciuleanu TE, Kanarev V, Wang H, Balakumaran A, Jacobs I. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012 Dec;7(12):1823-1829. doi: 10.1097/JTO.0b013e31826aec2b. |
| 22851406 | Background | Vadhan-Raj S, von Moos R, Fallowfield LJ, Patrick DL, Goldwasser F, Cleeland CS, Henry DH, Novello S, Hungria V, Qian Y, Feng A, Yeh H, Chung K. Clinical benefit in patients with metastatic bone disease: results of a phase 3 study of denosumab versus zoledronic acid. Ann Oncol. 2012 Dec;23(12):3045-3051. doi: 10.1093/annonc/mds175. Epub 2012 Jul 31. |
| 29972647 | Derived | Abdel-Rahman O. Predictors of skeletal-related events among cancer patients with bone metastases treated with zoledronic acid: a secondary analysis of a randomized study. Expert Opin Drug Saf. 2018 Aug;17(8):757-761. doi: 10.1080/14740338.2018.1497157. Epub 2018 Jul 11. |
| 26093811 | Derived | Body JJ, Bone HG, de Boer RH, Stopeck A, Van Poznak C, Damiao R, Fizazi K, Henry DH, Ibrahim T, Lipton A, Saad F, Shore N, Takano T, Shaywitz AJ, Wang H, Bracco OL, Braun A, Kostenuik PJ. Hypocalcaemia in patients with metastatic bone disease treated with denosumab. Eur J Cancer. 2015 Sep;51(13):1812-21. doi: 10.1016/j.ejca.2015.05.016. Epub 2015 Jun 17. |
| 25976743 | Derived | Diel IJ, Body JJ, Stopeck AT, Vadhan-Raj S, Spencer A, Steger G, von Moos R, Goldwasser F, Feng A, Braun A. The role of denosumab in the prevention of hypercalcaemia of malignancy in cancer patients with metastatic bone disease. Eur J Cancer. 2015 Jul;51(11):1467-75. doi: 10.1016/j.ejca.2015.04.017. Epub 2015 May 11. |
| 23975226 | Derived | von Moos R, Body JJ, Egerdie B, Stopeck A, Brown JE, Damyanov D, Fallowfield LJ, Marx G, Cleeland CS, Patrick DL, Palazzo FG, Qian Y, Braun A, Chung K. Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid. Support Care Cancer. 2013 Dec;21(12):3497-507. doi: 10.1007/s00520-013-1932-2. Epub 2013 Aug 22. |
| 22975218 | Derived | Lipton A, Fizazi K, Stopeck AT, Henry DH, Brown JE, Yardley DA, Richardson GE, Siena S, Maroto P, Clemens M, Bilynskyy B, Charu V, Beuzeboc P, Rader M, Viniegra M, Saad F, Ke C, Braun A, Jun S. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012 Nov;48(16):3082-92. doi: 10.1016/j.ejca.2012.08.002. Epub 2012 Sep 10. |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Participant request |
|
| Lost to Follow-up |
|
| Noncompliance |
|
| Physician Decision |
|
| Protocol deviation |
|
| Ineligibility determined |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Tumor Type Stratification Factor | Number | Participants |
|
| Previous Skeletal-Related Event Stratification Factor | Number | Participants |
|
| Systematic Anti-Cancer Therapy Stratification Factor | Number | Participants |
|
|
|
|
| Secondary | Time to First On-Study Skeletal-Related Event (Superiority) | Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method. | Full Analysis Set, composed of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | up to 33 months |
|
|
|
|
| Secondary | Time to the First-and-Subsequent On-Study Skeletal-Related Event | Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events. | Full Analysis Set, composed of all randomized participants | Posted | Number | Events | up to 33 months |
|
|
|
|
| 581 |
| 878 |
| 767 |
| 878 |
| EG001 | Denosumab 120 mg Q4W | 552 | 878 | 751 | 878 |
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardio-respiratory distress | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paroxysmal arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Caecitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sigmoiditis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Euthanasia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Inflammation of wound | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Organ failure | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatorenal failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal wall infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cavernous sinus thrombosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis fungal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Osteomyelitis acute | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia haemophilus | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary mycosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Purulent discharge | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyothorax | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Rectal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Device dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Lung injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Stent-graft endoleak | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood potassium | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Monoclonal immunoglobulin present | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Sputum abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cervix cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to abdominal cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to bone marrow | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to gastrointestinal tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to rectum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngeal neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour thrombosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Apraxia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cauda equina syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cervical cord compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cervical root pain | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coma uraemic | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epiduritis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Polyneuropathy alcoholic | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Psychomotor skills impaired | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bladder mass | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephroangiosclerosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urethral obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orchitis noninfective | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Immobile | Social circumstances | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal wall operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aortic occlusion | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arteritis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Superior vena caval occlusion | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |