Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001967-70 | EudraCT Number |
Not provided
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Not provided
Not provided
Not provided
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The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosentan | Experimental | Bosentan was administered at 4 mg/kg twice daily (b.i.d.) until the end of the study. It could be down-titrated to 2 mg/kg b.i.d. if not well tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug | 32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study (EOS) in Height for Age. | In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula: Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
| Change From Baseline to End of Study (EOS) in Body Weight | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height. | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
| Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP) | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure. | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
| Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP) | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure. | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
Not provided
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andjela Kusic-Pajic, MD | Actelion | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26386921 | Result | Berger RM, Haworth SG, Bonnet D, Dulac Y, Fraisse A, Galie N, Ivy DD, Jais X, Miera O, Rosenzweig EB, Efficace M, Kusic-Pajic A, Beghetti M. FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion. Int J Cardiol. 2016 Jan 1;202:52-8. doi: 10.1016/j.ijcard.2015.08.080. Epub 2015 Aug 9. |
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The actual number of patients enrolled in FUTURE 2 (F-2) was 33 because 2 patients did not complete FUTURE 1 (F-1) and one patient completed F-1 but was not enrolled in F-2.
36 Children ( >= 2 years and < 12 years) with idiopathic or familial pulmonary arterial hypertension were recruited from 11 centers across Europe and USA and enrolled in the FUTURE 1 trial (baseline). Only patients who completed FUTURE 1 (n=34) could be enrolled in FUTURE 2. Enrollment in FUTURE 2 started August 23, 2005.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Previous Bosentan | This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiatied at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated). Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen. |
| FG001 | Bosentan-naive Patients | This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for "Patients with previous bosentan". Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Previous Bosentan | This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change From Baseline to End of Study (EOS) in Height for Age. | In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula: Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Median | Full Range | Z-score | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
|
From the first administration of study treatment and for an average of 31 months for frequent adverse events (up to 1 day after study treatment discontinuation), and for an average of 32 months (up to 28 days after study treatment discontinuation) for serious adverse events
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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 | Patients With Previous Bosentan | Patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| clinical trial disclosure desk | Actelion Pharmaceuticals Ltd | clinical-trials-disclosure@actelion.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Change From Baseline to End of Study (EOS) in Pulse Rate | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in pulse rate. | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
| Proportion of Patients With Treatment-emergent Liver Function Abnormalities | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes. Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here. | After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average |
| Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities. Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here. | After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average |
| Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment | From the first study drug administration in FUTURE 1, for an average of 31 months |
| F-1 completed but not enrolled in F-2 |
|
| Administrative reason |
|
| Disease progression |
|
| Transplant |
|
| Treatment failure |
|
| Adverse Event |
|
| BG001 | Bosentan-naive Patients | This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for "Patients with previous bosentan". Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Etiology of pulmonary arterial hypertension (PAH) | Children included in the study had a diagnosis of pulmonary arterial hypertension (PAH) belonging to one of the following two categories: 1- Idiopathic PAH, 2- Familal PAH | Number | Participants |
|
| Duration of pulmonary arterial hypertension (PAH) | Median | Full Range | Months |
|
This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated). |
| OG001 | Bosentan-naive Patients | This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for "Patients with previous bosentan". Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen. |
| OG002 | Total | All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods. |
|
|
| Primary | Change From Baseline to End of Study (EOS) in Body Weight | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height. | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Median | Full Range | kg | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
|
|
|
| Primary | Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP) | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure. | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Median | Full Range | mmHg | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
|
|
|
| Primary | Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP) | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure. | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Median | Full Range | mmHg | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
|
|
|
| Primary | Change From Baseline to End of Study (EOS) in Pulse Rate | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in pulse rate. | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Median | Full Range | Beats per minutes | From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average |
|
|
|
| Primary | Proportion of Patients With Treatment-emergent Liver Function Abnormalities | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes. Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here. | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Number | Percentage of participants | After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average |
|
|
|
| Primary | Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities | The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities. Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here. | All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing. | Posted | Number | Percentage of participants | After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average |
|
|
|
| Primary | Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment | Posted | Number | Participants | From the first study drug administration in FUTURE 1, for an average of 31 months |
|
|
|
| 9 |
| 15 |
| 12 |
| 15 |
| EG001 | Bosentan_naive Patients | Patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2 | 9 | 21 | 16 | 21 |
| EG002 | Single Arm Bosentan_Total | All patients included in Future 1 / FUTURE 2 whether they received bosentan or not bosentan before enrollment in FUTURE 1 | 18 | 36 | 26 | 36 |
| ADENOIDECTOMY | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| ARTERIAL CATHETERISATION | Investigations | MedDRA | Systematic Assessment |
|
| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| BACTERAEMIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| BALLOON ATRIAL SEPTOSTOMY | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| BRONCHIAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| BRONCHITIS VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
|
| CATHETER SITE INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| CATHETERISATION CARDIAC | Investigations | MedDRA | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| DIAPHRAGMATIC HERNIA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| DYSTONIA | Nervous system disorders | MedDRA | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
| INJECTION SITE NODULE | General disorders | MedDRA | Systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| LOBAR PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| MEDICAL DEVICE COMPLICATION | General disorders | MedDRA | Systematic Assessment |
|
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| PNEUMONIA VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
|
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PULMONARY ARTERIAL PRESSURE | Investigations | MedDRA | Systematic Assessment |
|
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PULMONARY VEIN STENOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| SYSTEMIC-PULMONARY ARTERY SHUNT | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| VIRAL RHINITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ADVERSE DRUG REACTION | General disorders | MedDRA | Systematic Assessment |
|
| AGGRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| CYANOSIS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| ENURESIS | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA | Systematic Assessment |
|
| H1N1 INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ALLERGY TO PLANTS | Immune system disorders | MedDRA | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| CATHETER SITE PAIN | General disorders | MedDRA | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| GASTROINTESTINAL VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| NIPPLE SWELLING | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PERTUSSIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| PHOTOPHOBIA | Eye disorders | MedDRA | Systematic Assessment |
|
| TOOTH DISCOLOURATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA | Systematic Assessment |
|
Any study-related article or abstract written independently by investigators should be submitted to Actelion for review at least 60 days prior to submission for publication or presentation.
| 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 |
|
|
|
|
| Title | Measurements |
|---|---|
|