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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
Not provided
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The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-4208-1 | Experimental | 88 mcg |
|
| TD-4208-2 | Experimental | 175 mcg |
|
| Tiotropium | Active Comparator | 18 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-4208 | Drug | Subjects receiving TD-4208 are blinded to one of two doses of 4208. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events: Frequency and Severity | To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE) | Baseline to Day 365 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmetto Medical Research Associates L.L.C | Easley | South Carolina | 29640 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38560416 | Derived | Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024. | |
| 32343967 | Derived | Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TD-4208-1 | 88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. |
| FG001 | TD-4208-2 | 175 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. |
| FG002 | Tiotropium | 18 mcg Tiotropium: Active comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1060 subjects were randomized. A total of 1055 subjects received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TD-4208-1 | 88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. |
| BG001 | TD-4208-2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Adverse Events: Frequency and Severity | To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE) | Posted | Count of Participants | Participants | Baseline to Day 365 |
|
Adverse events were recorded from signing of the ICF through the final follow-up assessment (approximately 1 year)
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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 | TD-4208-1 | 88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development & Medical Affairs | Theravance Biopharma | 1-855-633-8479 | medinfo@theravance.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2016 | Dec 1, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 13, 2017 | Nov 29, 2018 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| C583570 | revefenacin |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
Not provided
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| Tiotropium | Drug | There is not a placebo, there is an active comparator (Tiotropium) arm. |
|
| 31666076 | Derived | Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). Respir Res. 2019 Oct 30;20(1):241. doi: 10.1186/s12931-019-1187-7. |
| 31150963 | Derived | Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2019 Jul;153:38-43. doi: 10.1016/j.rmed.2019.05.010. Epub 2019 May 23. |
175 mcg
TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
| BG002 | Tiotropium | 18 mcg Tiotropium: Active comparator |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
|
|
| 1 |
| 364 |
| 58 |
| 364 |
| 202 |
| 364 |
| EG001 | TD-4208-2 | 175 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. | 1 | 335 | 43 | 335 | 166 | 335 |
| EG002 | Tiotropium | 18 mcg Tiotropium: Active comparator | 1 | 356 | 58 | 356 | 188 | 356 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lung adenocarcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrointestinal angiodysplasia haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac death | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Near drowning | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Diverticulitis intestinal haemorrhagic | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Ludwig angina | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Ear neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Laryngeal squamouse cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Prostate cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Small initestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |