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| ID | Type | Description | Link |
|---|---|---|---|
| COMPASS-2 | Other Identifier | Actelion Pharmaceuticals Ltd |
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COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to being randomized.
The study continued until the predefined target number of morbidity/mortality events was reached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Bosentan |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bosentan | Drug | bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Confirmed Morbidity/Mortality Event up to the End of Study | Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as "moderately" or "markedly" worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied "no change" or "mildly worse" on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event. | From baseline to end of study, approximately 86 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation | Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee. |
Not provided
Inclusion Criteria:
Signed informed consent prior to initiation of any study-mandated procedure
Males or females >=12 years of age (except for countries where this age limit is contrary to specific regulatory requirements).
- Women of childbearing potential must have a negative pretreatment pregnancy test and must use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
·Reliable methods of contraception are:
O Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
O Intrauterine devices. O Oral, transdermal, injectable or implantable contraceptives only in combination with a barrier method.
Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception.
Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
Patients with symptomatic PAH
Patients with the following types of PAH belonging to WHO Group I:
Idiopathic (IPAH)
Familial (FPAH)
Associated with (APAH):
i. Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii. Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair iii. Drugs and toxins
PAH diagnosed by right heart catheter showing:
Treatment with a stable dose of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to randomization (no sildenafil dosage adjustment should occur in this period) 7)150 m =< 6-minute walk test (6MWT) =< 480 m, documented by 2 tests with second 6MWT within 15% of first 6MWT distance or a third test required
Exclusion Criteria :
PAH belonging to WHO group II-V
PAH associated with portal hypertension and HIV infection
PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy
PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg): pulmonary veno-occlusive disease and pulmonary capillary hemangiomatosis
Persistent pulmonary hypertension of the newborn
Significant valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization (i.e. patients with tricuspid or pulmonary insufficiency secondary to PAH can be included)
Restrictive lung disease: total lung capacity (TLC) < 60% of normal predicted value (see Appendix 3)
Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
Known HIV infection
Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements or that may interfere with the safety or the evaluation of the study, such as chronic infection, chronic renal failure etc.
Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
Pregnancy or breast-feeding
Condition that prevents compliance with the protocol or adherence to therapy
Systolic blood pressure < 85 mmHg
Body weight < 40 kg
Hemoglobin <75% of the lower limit of the normal range
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal ranges
Known hypersensitivity or history of drug-related adverse events with bosentan (e.g. increase in liver function test results), or any of the excipients of its formulation
Receipt of an investigational product other than sildenafil within 3 months before start of study treatment
Treatment with endothelin receptor antagonists (ERAs), prostanoids or phosphodiesterase (PDE) 5 inhibitors other than sildenafil within 3 months prior to randomization
Concomitant systemic treatment within 1 week prior to randomization with
Treatment with nitrates and alpha-blockers at time of randomization
In the opinion of the investigator - patients in need for treatment with any prostanoid up to Visit 4
Significant left ventricular dysfunction
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26113687 | Derived | McLaughlin V, Channick RN, Ghofrani HA, Lemarie JC, Naeije R, Packer M, Souza R, Tapson VF, Tolson J, Al Hiti H, Meyer G, Hoeper MM. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J. 2015 Aug;46(2):405-13. doi: 10.1183/13993003.02044-2014. Epub 2015 Jun 25. |
| Label | URL |
|---|---|
| Tracleer for PAH approval page at Drugs@FDA.gov | View source |
Not provided
There was a screening period of up to 14 days to assess eligibility. A total of 377 patients were screened.
First subject, first visit was17 May 2006 and last subject, last visit was 05 Dec 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bosentan | Bosentan bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d. |
| FG001 | Placebo | Placebo placebo: Matching bosentan placebo/b.i.d. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bosentan | Bosentan bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d. |
| BG001 | Placebo | Placebo placebo: Matching bosentan placebo/b.i.d. |
| 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 Confirmed Morbidity/Mortality Event up to the End of Study | Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as "moderately" or "markedly" worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied "no change" or "mildly worse" on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event. | All randomized set | Posted | Number | percentage of participants-Kaplan Meier | From baseline to end of study, approximately 86 months |
|
Up to End of Study and up to 1 day after discontinuation of study treatment, approximately 86 weeks
All treated patients. Treatment emergent adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosentan | Bosentan bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OEDEMA PERIPHERAL | General disorders | MedDRA version 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Tolson | Actelion Pharmaceuticals Ltd | +41 61 565 56 04 | jonathon.tolson@actelion.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
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| placebo |
| Drug |
Matching bosentan placebo/b.i.d. |
|
| Baseline to end of study, approximately 86 months |
| Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT) | The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period. | From baseline to week 16 |
| Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16 | Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA. | From baseline to Week 16 |
| Time to Death of All Causes From Baseline to End of Study | Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause. | Baseline to End of Study, approximately 86 months |
| Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP) | Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory. | Baseline to Month 20 |
| Change From Baseline to Week 16 in Borg Dyspnea Index | The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). | Baseline to Week 16 |
| Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score | The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome). | From baseline to Week 16 |
| Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score | The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0. | Baseline to Week 16 |
| Patient Global Self Assessment (PGSA) Status at Week 16 | The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question "How do you feel about your PAH today compared with your last visit?" asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse. | Week 16 |
| Lost to Follow-up |
|
| Administrative reason |
|
| Decision by the investigator |
|
| Lung transplantation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Bosentan bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d. |
| OG001 | Placebo | Placebo placebo: Matching bosentan placebo/b.i.d. |
|
|
|
| Secondary | Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation | Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee. | All randomized set | Posted | Number | percentage of participants-Kaplan Meier | Baseline to end of study, approximately 86 months |
|
|
|
|
| Secondary | Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT) | The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period. | All randomized set | Posted | Mean | Standard Deviation | m | From baseline to week 16 |
|
|
|
|
| Secondary | Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16 | Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA. | All randomized set | Posted | Number | participants | From baseline to Week 16 |
|
|
|
|
| Secondary | Time to Death of All Causes From Baseline to End of Study | Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause. | All randomized set | Posted | Number | percentage of participants-Kaplan Meier | Baseline to End of Study, approximately 86 months |
|
|
|
|
| Secondary | Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP) | Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory. | All randomized patients with a baseline and at least one post-baseline value. Assessments considered are those where at least 60% of the patients have a post-baseline value | Posted | Geometric Mean | 95% Confidence Interval | Adjusted percentage ratio from baseline | Baseline to Month 20 |
|
|
|
|
| Secondary | Change From Baseline to Week 16 in Borg Dyspnea Index | The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). | All randomized set | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
|
|
|
|
| Secondary | Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score | The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome). | All randomized set | Posted | Mean | Standard Deviation | units on a scale | From baseline to Week 16 |
|
|
|
|
| Secondary | Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score | The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0. | All randomized set | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
|
|
|
|
| Secondary | Patient Global Self Assessment (PGSA) Status at Week 16 | The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question "How do you feel about your PAH today compared with your last visit?" asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse. | All randomized set, patients who completed the assessment | Posted | Number | participants | Week 16 |
|
|
|
| 73 |
| 159 |
| 135 |
| 159 |
| EG001 | Placebo | Placebo placebo: Matching bosentan placebo/b.i.d. | 102 | 174 | 147 | 174 |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHRONIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHIAL HYPERREACTIVITY | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| OBLITERATIVE BRONCHIOLITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHIAL HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ORTHOPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| DENGUE FEVER | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| GASTROENTERITIS SALMONELLA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMATOMA INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| PNEUMOCOCCAL SEPSIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| BACTERAEMIA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHITIS VIRAL | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| ERYSIPELAS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| GASTROENTERITIS CALICIVIRAL | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| H1N1 INFLUENZA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| INFECTED DERMAL CYST | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| KLEBSIELLA BACTERAEMIA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| SEPSIS SYNDROME | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| TUBERCULOSIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| COR PULMONALE | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ACUTE RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| TRIFASCICULAR BLOCK | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BRADYARRHYTHMIA | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| INTRACARDIAC THROMBUS | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DIVERTICULUM | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SUDDEN DEATH | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GENERALISED OEDEMA | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ADVERSE DRUG REACTION | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DEATH | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPERVOLAEMIA | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| GOUT | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| RENAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| TRANSFUSION-RELATED ACUTE LUNG INJURY | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| FRACTURED SACRUM | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| VASCULAR RESISTANCE PULMONARY INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ANAEMIA HAEMOLYTIC AUTOIMMUNE | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SPLENOMEGALY | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPERSPLENISM | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| THROMBOTIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BRAIN STEM STROKE | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HEMIPARESIS | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| LUMBAR RADICULOPATHY | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CORONARY ARTERY BYPASS | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| DIURETIC THERAPY | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| FINGER AMPUTATION | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| INCISIONAL HERNIA REPAIR | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| CHEMOTHERAPY | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| RADIOTHERAPY | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| SKIN CYST EXCISION | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| SKIN NEOPLASM EXCISION | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| THYMECTOMY | Surgical and medical procedures | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHIOLOALVEOLAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| DIFFUSE LARGE B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| ACOUSTIC NEUROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHIAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| INFLAMMATORY CARCINOMA OF THE BREAST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| MALIGNANT MELANOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| MENINGIOMA BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
|
| BIPOLAR I DISORDER | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
| OVARIAN MASS | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
| UTERINE PROLAPSE | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| EXTREMITY NECROSIS | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| FEMORAL ARTERY OCCLUSION | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RETINAL DETACHMENT | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| EYE SWELLING | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BILIARY DYSKINESIA | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHOLESTASIS | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PORTAL HYPERTENSION | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| COLLAGEN DISORDER | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CREST SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DUPUYTREN'S CONTRACTURE | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMARTHROSIS | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BLADDER NECK OBSTRUCTION | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| RENAL TUBULAR NECROSIS | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SUDDEN HEARING LOSS | Ear and labyrinth disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA version 16.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA version 16.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
|
Not provided
| D002318 |
| Cardiovascular Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Kaplan-Meier estimate at Month 12 |
|
| Kaplan-Meier estimate at Month 16 |
|
| Kaplan-Meier estimate at Month 20 |
|
| Kaplan-Meier estimate at Month 24 |
|
| Kaplan-Meier estimate at Month 28 |
|
| Kaplan-Meier estimate at Month 32 |
|
| Kaplan-Meier estimate at Month 36 |
|
| Kaplan-Meier estimate at Month 40 |
|
| Kaplan-Meier estimate at Month 44 |
|
| Kaplan-Meier estimate at Month 48 |
|
| Kaplan-Meier estimate at Month 52 |
|
| Kaplan-Meier estimate at Month 56 |
|
| Kaplan-Meier estimate at Month 60 |
|
| Kaplan-Meier estimate at Month 64 |
|
| Kaplan-Meier estimate at Month 68 |
|
| Kaplan-Meier estimate at Month 72 |
|
| Kaplan-Meier estimate at Month 76 |
|
| Kaplan-Meier estimate at Month 80 |
|
| Kaplan-Meier estimate at Month 84 |
|
| Kaplan-Meier estimate at End of Study |
|
| Change from baseline |
|
| Worsened |
|
| Kaplan-Meier estimate at Month 12 |
|
| Kaplan-Meier estimate at Month 16 |
|
| Kaplan-Meier estimate at Month 20 |
|
| Kaplan-Meier estimate at Month 24 |
|
| Kaplan-Meier estimate at Month 28 |
|
| Kaplan-Meier estimate at Month 32 |
|
| Kaplan-Meier estimate at Month 36 |
|
| Kaplan-Meier estimate at Month 40 |
|
| Kaplan-Meier estimate at Month 44 |
|
| Kaplan-Meier estimate at Month 48 |
|
| Kaplan-Meier estimate at Month 52 |
|
| Kaplan-Meier estimate at Month 56 |
|
| Kaplan-Meier estimate at Month 60 |
|
| Kaplan-Meier estimate at Month 64 |
|
| Kaplan-Meier estimate at Month 68 |
|
| Kaplan-Meier estimate at Month 72 |
|
| Kaplan-Meier estimate at Month 76 |
|
| Kaplan-Meier estimate at Month 80 |
|
| Kaplan-Meier estimate at Month 84 |
|
| Kaplan-Meier estimate at End of Study |
|
| Month 8 to Baseline |
|
| Month 12 to Baseline |
|
| Month 16 to Baseline |
|
| Month 20 to Baseline |
|
| Treatment effect over 20 months |
|
| Change from baseline |
|
| Change from Baseline |
|
| Change from Baseline |
|
| Mildly better |
|
| No change |
|
| Mildly worse |
|
| Moderately worse |
|
| Markedly worse |
|