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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 in men with hormone-refractory prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zoledronic acid | Active Comparator |
| |
| denosumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First On-Study SRE (Non-inferiority) | Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported. | Up to 40.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First On-Study SRE (Superiority) | Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported. | Up to 40.5 months |
| Time to the First-And-Subsequent On-Study SRE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21353695 | Background | Fizazi K, Carducci M, Smith M, Damiao R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. doi: 10.1016/S0140-6736(10)62344-6. Epub 2011 Feb 25. | |
| 25425475 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
1904 participants were enrolled, however 3 were excluded from all analyses as Institutional Review Board review activities and oversight were not ensured.
Participants were enrolled from 12 May 2006 through 18 December 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 subcutaneously 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 subcutaneously 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 SRE (Non-inferiority) | Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported. | Full Analysis Set, composed of all randomized participants | Posted | Median | 95% Confidence Interval | Days | Up to 40.5 months |
|
up to 3 years 5 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
One subject who was randomized to zoledronic acid and received denosumab as the 1st investigational product was analyzed on the denosumab arm for safety analyses.
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 |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| denosumab | Biological | Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes |
|
Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, 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 40.5 months |
| Background |
| Smith MR, Coleman RE, Klotz L, Pittman K, Milecki P, Ng S, Chi KN, Balakumaran A, Wei R, Wang H, Braun A, Fizazi K. Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer: comparison of skeletal-related events and symptomatic skeletal events. Ann Oncol. 2015 Feb;26(2):368-74. doi: 10.1093/annonc/mdu519. Epub 2014 Nov 25. |
| 25449207 | Background | Fizazi K, Massard C, Smith M, Rader M, Brown J, Milecki P, Shore N, Oudard S, Karsh L, Carducci M, Damiao R, Wang H, Ying W, Goessl C. Bone-related Parameters are the Main Prognostic Factors for Overall Survival in Men with Bone Metastases from Castration-resistant Prostate Cancer. Eur Urol. 2015 Jul;68(1):42-50. doi: 10.1016/j.eururo.2014.10.001. Epub 2014 Oct 29. |
| 33270906 | Derived | Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2. |
| 26335402 | Derived | Stopeck AT, Fizazi K, Body JJ, Brown JE, Carducci M, Diel I, Fujiwara Y, Martin M, Paterson A, Tonkin K, Shore N, Sieber P, Kueppers F, Karsh L, Yardley D, Wang H, Maniar T, Arellano J, Braun A. Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer. Support Care Cancer. 2016 Jan;24(1):447-455. doi: 10.1007/s00520-015-2904-5. Epub 2015 Sep 3. |
| 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. |
| 24722180 | Derived | de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10. |
| 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. |
| Disease progression |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Noncompliance |
|
| Protocol deviation |
|
| Ineligibility determined |
|
| Participant request |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Prostate-Specific Antigen (PSA) Stratification Factor | Number | Participants |
|
| Previous Skeletal-Related Event (SRE) Stratification Factor | Number | Participants |
|
| Current Prostate Cancer Chemotherapy Stratification Factor | Defined as within 6 weeks before randomization | Number | Participants |
|
|
|
|
| Secondary | Time to the First On-Study SRE (Superiority) | Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported. | Full Analysis Set, composed of all randomized participants | Posted | Median | 95% Confidence Interval | Days | Up to 40.5 months |
|
|
|
|
| Secondary | Time to the First-And-Subsequent On-Study SRE | Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, 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 40.5 months |
|
|
|
|
| 568 |
| 945 |
| 853 |
| 945 |
| EG001 | Denosumab 120 mg Q4W | 594 | 943 | 844 | 943 |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac asthma | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Retinal artery thrombosis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rectal stenosis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rectourethral fistula | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Reflux gastritis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abasia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Terminal state | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Biliary tract disorder | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholelithiasis obstructive | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Alveolar osteitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Central line infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Dermo-hypodermitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Endotoxaemia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Fungal oesophagitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Ludwig angina | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Penile abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Peridiverticulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Post procedural sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Renal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Tongue abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac pacemaker malfunction | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Device failure | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Device malfunction | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Medical device discomfort | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Renal haematoma | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Aspiration bronchial | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood creatinine | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood pressure systolic abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| General physical condition abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Glomerular filtration rate | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| International normalised ratio decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Feeding disorder | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypermetabolism | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperosmolar state | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sarcopenia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to bone marrow | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastases to rectum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Nasal sinus cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Waldenstrom's macroglobulinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Brown-Sequard syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cauda equina syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cervical cord compression | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diabetic hyperglycaemic coma | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diplegia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epidural lipomatosis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertonia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Radicular syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Spinal cord ischaemia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypochondriasis | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sopor | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Faecaluria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urethral haemorrhage | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urethral obstruction | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Genital pain | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema genital | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Prostatic cyst | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Prostatic disorder | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Walking disability | Social circumstances | MedDRA 12.1 | Systematic Assessment |
|
| Catheter placement | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Ostectomy | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Ureteral stent insertion | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Extrinsic vascular compression | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | 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.
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |