Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GA29960 | Other Identifier | Genentech |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
Not provided
Not provided
Not provided
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This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol.
Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone.
The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | pirfenidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pirfenidone | Drug | Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause. | 7.5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genentech, Inc. | South San Francisco | California | 94080-4990 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37391667 | Derived | Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30. | |
| 30950636 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pirfenidone | Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pirfenidone | Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily. |
| 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 | Percentage of Participants With Adverse Events | An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause. | All participants who received any pirfenidone. | Posted | Number | percentage of participants | 7.5 years |
|
|
7.5 years
Adverse events were recorded at every contact with the participant.
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 | Pirfenidone | Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA, Version 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093844 | pirfenidone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Maher TM, Lancaster LH, Jouneau S, Morrison L, Lederer DJ, Molina-Molina M, Bendstrup E, Kirchgaessler KU, Gilberg F, Axmann J, Petzinger U, Noble PW. Pirfenidone Treatment in Individuals with Idiopathic Pulmonary Fibrosis: Impact of Timing of Treatment Initiation. Ann Am Thorac Soc. 2019 Jul;16(7):927-930. doi: 10.1513/AnnalsATS.201810-720RL. No abstract available. |
| 28898890 | Derived | Costabel U, Albera C, Lancaster LH, Lin CY, Hormel P, Hulter HN, Noble PW. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP). Respiration. 2017;94(5):408-415. doi: 10.1159/000479976. Epub 2017 Sep 13. |
| 26835133 | Derived | Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016. |
| Sponsor decision |
|
| Physician Decision |
|
| Lung transplantation |
|
| Lost to Follow-up |
|
| Death |
|
| Adverse Event |
|
| Continued treatment |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 571 |
| 1,058 |
| 1,027 |
| 1,058 |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute right ventricular failure | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Coronary artery dissection | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Heart valve incompetence | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Right ventricular dysfunction | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Colonic fistula | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Jejunal perforation | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Oesophageal perforation | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Polyarteritis nodosa | Immune system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bacterial abscess central nervous system | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bartonellosis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchiectasis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Campylobacter intestinal infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Endocarditis enterococcal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Fungal oesophagitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Herpes zoster oticus | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia herpes viral | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Postoperative abscess | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Device lead damage | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Failure of implant | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Renal haematoma | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Renal injury | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Struck by lightning | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Mycobacteria blood test positive | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Panel-reactive antibody increased | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary arterial pressure increased | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Tumour marker increased | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Large cell carcinoma of the respiratory tract stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung adenocarcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Malignant melanoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Non-small cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Oesophageal adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Oesophageal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ovarian cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 11.0 | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cerebral thrombosis | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Mononeuropathy multiplex | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Endosalpingiosis | Reproductive system and breast disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pelvic floor muscle weakness | Reproductive system and breast disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumothorax spontaneous tension | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary cavitation | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Air embolism | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Vasculitis necrotising | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA, Version 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA, Version 11.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |