Not provided
Not provided
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zoledronic acid | Active Comparator |
| |
| denosumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Biological | Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented. | Up to 34 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 superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented. | Up to 34 months |
| Time to First and Subsequent On-Study Skeletal-Related Event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22951813 | Background | Cleeland CS, Body JJ, Stopeck A, von Moos R, Fallowfield L, Mathias SD, Patrick DL, Clemons M, Tonkin K, Masuda N, Lipton A, de Boer R, Salvagni S, Oliveira CT, Qian Y, Jiang Q, Dansey R, Braun A, Chung K. Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid. Cancer. 2013 Feb 15;119(4):832-8. doi: 10.1002/cncr.27789. Epub 2012 Sep 5. | |
| 22893628 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
2049 patients were enrolled in the study, but 3 patients were excluded from all analyses because properly documented informed consent was not obtained.
Participants were enrolled from 27 April 2006 through 31 December 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid | Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks |
| FG001 | Denosumab | Denomsumab 120 mg subcutaneously with 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 subcutaneous denosumab placebo once every 4 weeks |
| BG001 | Denosumab | Denomsumab 120 mg subcutaneously with 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 First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented. | Full Analysis Set, composed of all randomized participants. | Posted | Number | Participants | Up to 34 months |
|
up to 2 years 10 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 12.0 | 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 |
|---|---|
| D050723 | Fractures, Bone |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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 | Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC |
|
|
Time to first and subsequent on-study skeletal-related event (SRE) using a 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 number of events. |
| Up to 34 months |
| Background |
| Martin M, Bell R, Bourgeois H, Brufsky A, Diel I, Eniu A, Fallowfield L, Fujiwara Y, Jassem J, Paterson AH, Ritchie D, Steger GG, Stopeck A, Vogel C, Fan M, Jiang Q, Chung K, Dansey R, Braun A. Bone-related complications and quality of life in advanced breast cancer: results from a randomized phase III trial of denosumab versus zoledronic acid. Clin Cancer Res. 2012 Sep 1;18(17):4841-9. doi: 10.1158/1078-0432.CCR-11-3310. Epub 2012 Aug 14. |
| 21060033 | Background | Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010 Dec 10;28(35):5132-9. doi: 10.1200/JCO.2010.29.7101. Epub 2010 Nov 8. |
| 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. |
| 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 |
|
| Participant request |
|
| Adverse Event |
|
| Physician Decision |
|
| Noncompliance |
|
| Lost to Follow-up |
|
| 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 |
|
| Previous Skeletal-Related Event Stratification Factor | Number | Participants |
|
| Prior Oral Bisphosphonate Use Stratification Factor | Number | Participants |
|
| Current Chemotherapy Stratification Factor | Defined as within 6 weeks before randomization | Number | Participants |
|
| Japan Stratification Factor | Participant located in Japan | Number | Participants |
|
|
|
|
| Secondary | Time to First On-Study Skeletal-Related Event (Superiority) | Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented. | Full Analysis Set, composed of all randomized participants. | Posted | Number | Participants | Up to 34 months |
|
|
|
|
| Secondary | Time to First and Subsequent On-Study Skeletal-Related Event | Time to first and subsequent on-study skeletal-related event (SRE) using a 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 number of events. | Full Analysis Set, composed of all randomized participants | Posted | Number | Events | Up to 34 months |
|
|
|
|
| 471 |
| 1,013 |
| 941 |
| 1,013 |
| EG001 | Denosumab 120 mg Q4W | 453 | 1,020 | 924 | 1,020 |
| 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 |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphadenopathy | 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 |
|
| Platelet disorder | 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 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 |
|
| Arteriospasm coronary | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac arrest | 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 |
|
| 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 |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cytotoxic cardiomyopathy | 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 |
|
| Palpitations | 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 bradycardia | 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 |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Endocrine disorder | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Amaurosis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Exophthalmos | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ulcerative keratitis | 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 discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal 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 |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Caecitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enterocele | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ileus | 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 |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Large intestine perforation | 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 |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal haemorrhage | 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 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Catheter site pain | 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 |
|
| Condition aggravated | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Crepitations | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | 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 |
|
| Impaired healing | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Implant expulsion | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Localised oedema | 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 |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic cyst | 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 |
|
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatorenal failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaundice | 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 |
|
| Anaphylactic shock | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal wall infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Breast cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Candida sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Catheter sepsis | 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 |
|
| Diabetic foot infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia sepsis | 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 |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Klebsiella sepsis | 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 bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Meningitis | 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 |
|
| Oral fungal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Periodontal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis chronic | 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 |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Stenotrophomonas sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tonsillitis | 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 |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis radiation | 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 |
|
| Incorrect route of drug administration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radiation injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radiation myelopathy | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Recall phenomenon | 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 |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Thermal burn | 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 |
|
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Wound dehiscence | 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 |
|
| Aspiration bronchial | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | 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 |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic foot | 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 |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis | 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 |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | 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 |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoarthritis | 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 |
|
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer metastatic | 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 |
|
| Chronic myeloid leukaemia | 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 |
|
| Contralateral breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lymphangiosis carcinomatosa | 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 |
|
| Meningioma | 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 biliary tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to bladder | 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 eye | 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 ovary | 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 skin | 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 |
|
| Metastases to uterus | 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 malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Paraneoplastic dermatomyositis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Pericarditis malignant | 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 |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Tumour haemorrhage | 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 |
|
| Aphasia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aphonia | 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 compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral infarction | 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 |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cervical cord compression | 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 |
|
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cranial nerve paralysis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dementia | 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 |
|
| Encephalopathy | 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 |
|
| Haemorrhagic stroke | 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 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Meningism | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Phrenic nerve paralysis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sciatica | 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 |
|
| Stupor | 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 |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Disorientation | 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 |
|
| Anuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | 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 pain | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ovarian mass | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectocele | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urogenital prolapse | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal prolapse | 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 |
|
| 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 |
|
| Dyspnoea | 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 |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydrothorax | 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 |
|
| Oropharyngeal pain | 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 |
|
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary hilum mass | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary hypertension | 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 depression | 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 |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal cavity drainage | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Arterial bypass operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Breast reconstruction | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Colostomy closure | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Oophorectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Pleurodesis | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Radical hysterectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Salpingo-oophorectomy bilateral | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Simple mastectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | 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 |
|
| Endocrine hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemodynamic instability | 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 |
|
| Iliac artery occlusion | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphangiopathy | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Venous thrombosis | 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 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Toothache | 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 |
|
| Chills | 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 |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | 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 |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 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 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | 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 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck 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 |
|
| Peripheral sensory neuropathy | 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 |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular 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.
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 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 |