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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000213-19 | EudraCT Number |
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The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.
The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. It was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. Study 99824 was therefore designed in collaboration with the CHMP as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. The duration of the treatment period was not fixed. No efficacy measures were included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertindole | Experimental | Normally in the range of 4 to 20 mg/day |
|
| Risperidone | Active Comparator | Normally in the range of 2 to 8 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertindole | Drug | Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-cause Mortality | The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18384186 | Result | Peuskens J, Tanghoj P, Mittoux A; Sertindole Cohort. The Sertindole Cohort Prospective (SCoP) study: rationale, design and methodology. Pharmacoepidemiol Drug Saf. 2008 May;17(5):425-33. doi: 10.1002/pds.1594. | |
| 20384598 | Result | Thomas SH, Drici MD, Hall GC, Crocq MA, Everitt B, Lader MH, Le Jeunne C, Naber D, Priori S, Sturkenboom M, Thibaut F, Peuskens J, Mittoux A, Tanghoj P, Toumi M, Moore ND, Mann RD. Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP). Acta Psychiatr Scand. 2010 Nov;122(5):345-55. doi: 10.1111/j.1600-0447.2010.01563.x. |
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593 centres in 38 countries (Europe and Asia). First patient first visit: 11 July 2002. Last patient last visit: 22 February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertindole | Normally in the range of 4 to 20 mg/day |
| FG001 | Risperidone | Normally in the range of 2 to 8 mg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertindole | Normally in the range of 4 to 20 mg/day |
| BG001 | Risperidone | Normally in the range of 2 to 8 mg/day |
| 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 | Number of Participants With All-cause Mortality | The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively | The analysis population included all patients who took at least one dose of study drug. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months.
Data on all serious adverse events and non-serious cardiac adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertindole | Normally in the range of 4 to 20 mg/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | Investigations | MedDRA (10.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C066304 | sertindole |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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|
|
| Risperidone | Drug | Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day |
|
|
| As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease | The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure | The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
| 20926264 | Result | Crocq MA, Naber D, Lader MH, Thibaut F, Drici M, Everitt B, Hall GC, Le Jeunne C, Mittoux A, Peuskens J, Priori S, Sturkenboom M, Thomas SH, Tanghoj P, Toumi M, Mann R, Moore ND. Suicide attempts in a prospective cohort of patients with schizophrenia treated with sertindole or risperidone. Eur Neuropsychopharmacol. 2010 Dec;20(12):829-38. doi: 10.1016/j.euroneuro.2010.09.001. |
| 20820795 | Result | De Hert M, Mittoux A, He Y, Peuskens J. Metabolic parameters in the short- and long-term treatment of schizophrenia with sertindole or risperidone. Eur Arch Psychiatry Clin Neurosci. 2011 Jun;261(4):231-9. doi: 10.1007/s00406-010-0142-x. Epub 2010 Sep 5. |
| 20732794 | Result | De Hert M, Mittoux A, He Y, Peuskens J. A head-to-head comparison of sertindole and risperidone on metabolic parameters. Schizophr Res. 2010 Nov;123(2-3):276-7. doi: 10.1016/j.schres.2010.07.030. Epub 2010 Aug 21. No abstract available. |
| Non-SAE: Mostly Asymptomatic ECGs |
|
| Non-compliance |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Pregnancy |
|
| Other |
|
| Non-evaluable: Patient on Polytherapy |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration of schizophrenia | Number | participants |
|
| Reasons for prescription of study drug | Number | participants |
|
| Number of previous suicide attempts | Number | participants |
|
| Time since last suicide attempt | Number | participants |
|
|
|
|
| Secondary | Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | The analysis population included all patients who took at least one dose of study drug. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Primary | Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation | The analysis population included all patients who took at least one dose of study drug. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. | The analysis population included all patients who took at least one dose of study drug. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease | The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period | The analysis population included all patients who took at least one dose of study drug. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| Secondary | Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure | The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study | The analysis population included all patients who took at least one dose of study drug. | Posted | Number | participants | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months |
|
|
|
|
| 266 |
| 4,905 |
| 397 |
| 4,905 |
| EG001 | Risperidone | Normally in the range of 2 to 8 mg/day | 217 | 4,904 | 11 | 4,904 |
| Blood disorder | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Torsade de pointes | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Eyelid disorder | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Meibomianitis | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Drowning | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hepatocellular damage | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Amoebic dysentery | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Infection in an immunocompromised host | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Meningitis tuberculous | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Obstructive chronic bronchitis with acute exacerbation | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Parasitic gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia chlamydial | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Burns third degree | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Multiple drug overdose intentional | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Self mutilation | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Medical observation | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Type 2 diabetis mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteoporosis postmenopausal | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Adrenal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Benign neoplasm of testis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Scrotal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Brain damage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diabetic coma | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypoxic encephalopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | MedDRA (10.1) | Non-systematic Assessment |
|
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA (10.1) | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (10.1) | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Suicidal behaviour | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Galactorrhoea | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Haematosalpinx | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Alcohol use | Social circumstances | MedDRA (10.1) | Non-systematic Assessment |
|
| Drug abuser | Social circumstances | MedDRA (10.1) | Non-systematic Assessment |
|
| Physical assault | Social circumstances | MedDRA (10.1) | Non-systematic Assessment |
|
| Social problem | Social circumstances | MedDRA (10.1) | Non-systematic Assessment |
|
| Treatment noncompliance | Social circumstances | MedDRA (10.1) | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Plastic surgery | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Labile hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
Publication of the results by the investigator will be subject to mutual agreement between the investigator and H. Lundbeck A/S.