Study the Safety and Effectiveness of Tadalafil on High B... | NCT00549302

ID	Type	Description	Link
H6D-MC-LVGX	Other Identifier	Eli Lilly and Company

Name	Class
ICOS Corporation	INDUSTRY

Label	Type	Description	Intervention Names
20 mg tadalafil	Active Comparator	20 milligram (mg) tadalafil taken once a day	Drug: tadalafil
40 mg tadalafil	Active Comparator	40 mg tadalafil tablet taken once a day	Drug: tadalafil

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug	20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH).

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.	Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)

Measure	Description	Time Frame
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52	6MWD measured the distance a participant was able to walk unassisted in 6 minutes.	Baseline and Weeks 16, 28, 40 and 52
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Bend	Oregon	97701

PubMed Identifier	Type	Citation	Retractions
22818063	Derived	Oudiz RJ, Brundage BH, Galie N, Ghofrani HA, Simonneau G, Botros FT, Chan M, Beardsworth A, Barst RJ; PHIRST Study Group. Tadalafil for the treatment of pulmonary arterial hypertension: a double-blind 52-week uncontrolled extension study. J Am Coll Cardiol. 2012 Aug 21;60(8):768-74. doi: 10.1016/j.jacc.2012.05.004. Epub 2012 Jul 18.

ID	Title	Description
FG000	Tadalafil 20 mg Double Blind	Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
FG001	Tadalafil 40 mg Double-Blind

ID	Title	Description
BG000	Tadalafil 20 Milligrams (mg) Double-Blind	Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
BG001	Tadalafil 40 mg Double-Blind	Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00063 BG001294 BG002357

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA(13)	Systematic Assessment		EG00011 events7 affected357 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Angina pectoris	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0003 events3 affected357 at risk
Angina unstable	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Arrhythmia	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Atrial fibrillation	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG00011 events7 affected357 at risk
Atrial flutter	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Atrial tachycardia	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cardiac arrest	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 3 participant deaths, 1 in the Tadalafil 40 mg arm and 2 in the Tadalafil 40 mg open-label arm	EG0005 events5 affected357 at risk
Cardiac failure	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 5 participant deaths 4 in the Tadalafil 40 mg open-label arm and 1 in the 30-day follow-up period after study drug discontinuation	EG00010 events9 affected357 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 3 participant deaths in the Tadalafil 40 mg open-label arm	EG00016 events10 affected357 at risk
Cardiac flutter	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0002 events2 affected357 at risk
Cardio-respiratory distress	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cardiogenic shock	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Cor pulmonale	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Coronary artery disease	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Cyanosis	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Myocardial infarction	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 3 participant deaths, 1 death in the Tadalafil 40 mg and 2 in the Tadalafil 40 mg open-label arm	EG0005 events4 affected357 at risk
Palpitations	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0003 events3 affected357 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Right ventricular failure	Cardiac disorders	MedDRA(13)	Systematic Assessment	Resulted in 9 participant deaths, 2 in the Tadalafil 40 mg arm and 7 in the Tadalafil 40 mg open-label arm	EG00036 events28 affected357 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0003 events3 affected357 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Vertigo	Ear and labyrinth disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hypothyroidism	Endocrine disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cataract	Eye disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Retinal detachment	Eye disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Visual disturbance	Eye disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Dental caries	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Gastric volvulus	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG00010 events8 affected357 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Chest discomfort	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Chest pain	General disorders	MedDRA(13)	Systematic Assessment		EG0009 events7 affected357 at risk
Chills	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cyst	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Death	General disorders	MedDRA(13)	Systematic Assessment	Resulted in 3 participant deaths, 1 in the Tadalafil 40 mg arm and 2 in the Tadalafil 40 mg open-label arm	EG0003 events3 affected357 at risk
Device malfunction	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Fatigue	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Injection site haemorrhage	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Medical device complication	General disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Non-cardiac chest pain	General disorders	MedDRA(13)	Systematic Assessment		EG0004 events4 affected357 at risk
Oedema peripheral	General disorders	MedDRA(13)	Systematic Assessment		EG0005 events5 affected357 at risk
Pyrexia	General disorders	MedDRA(13)	Systematic Assessment		EG0004 events3 affected357 at risk
Sensation of pressure	General disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Sudden cardiac death	General disorders	MedDRA(13)	Systematic Assessment	Resulted in 2 participant deaths in the Tadalafil 40 mg arm	EG0002 events2 affected357 at risk
Sudden death	General disorders	MedDRA(13)	Systematic Assessment	Resulted in 2 participant deaths, 1 in the Tadalafil 20 mg arm and another in the Tadalafil 40 mg open-label arm	EG0002 events2 affected357 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Bacteraemia	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Bronchiolitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Bronchitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0006 events6 affected357 at risk
Bronchitis bacterial	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Campylobacter infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Campylobacter intestinal infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cellulitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Clostridial infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cystitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Device related infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Diverticulitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Erysipelas	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Gastroenteritis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Gastroenteritis viral	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Influenza	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Lobar pneumonia	Infections and infestations	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Lung infection	Infections and infestations	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0003 events3 affected357 at risk
Mycobacterial infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Nasopharyngitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Parotitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Pneumonia	Infections and infestations	MedDRA(13)	Systematic Assessment	Resulted in 2 participant deaths, 1 in the Tadalafil 40 mg arm and another death in the Tadalafil 40 mg open-label arm	EG00019 events16 affected357 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Respiratory tract infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Sepsis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Septic shock	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Sinusitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Tracheobronchitis	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Urinary tract infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0003 events2 affected357 at risk
Viral infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Wound infection	Infections and infestations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Fall	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0005 events4 affected357 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA(13)	Systematic Assessment		EG0003 events2 affected357 at risk
Blood pressure increased	Investigations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
C-reactive protein increased	Investigations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cardiac output decreased	Investigations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
International normalised ratio increased	Investigations	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0006 events6 affected357 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0005 events4 affected357 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0003 events1 affected357 at risk
Systemic sclerosis	Musculoskeletal and connective tissue disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Leiomyosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg arm	EG0001 events1 affected357 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0002 events2 affected357 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Oropharyngeal cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Uterine leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Ataxia	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Cervical myelopathy	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Complicated migraine	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Dementia	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Dizziness	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Dystonia	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Headache	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Hypoaesthesia	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Presyncope	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Syncope	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG00010 events10 affected357 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Premature labour	Pregnancy, puerperium and perinatal conditions	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Anxiety disorder	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Bipolar disorder	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Confusional state	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Delirium	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Depression	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Emotional disorder	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Mental status changes	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Suicide attempt	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Withdrawal syndrome	Psychiatric disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Proteinuria	Renal and urinary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Renal failure	Renal and urinary disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Renal failure acute	Renal and urinary disorders	MedDRA(13)	Systematic Assessment		EG0007 events5 affected357 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Renal impairment	Renal and urinary disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0001 events1 affected357 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0004 events3 affected357 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0006 events5 affected357 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0005 events3 affected357 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0005 events4 affected357 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg open-label arm	EG0002 events2 affected357 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0005 events4 affected357 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0002 events1 affected357 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment	Resulted in 3 participant deaths in the Tadalafil 40 mg open-label arm	EG00028 events26 affected357 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0003 events3 affected357 at risk
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA(13)	Systematic Assessment	Resulted in 4 participant deaths in the Tadalafil 40 mg open-label arm	EG0006 events6 affected357 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA(13)	Systematic Assessment		EG0003 events3 affected357 at risk
Skin lesion excision	Surgical and medical procedures	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Aortic stenosis	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Circulatory collapse	Vascular disorders	MedDRA(13)	Systematic Assessment	Resulted in 1 participant death in the Tadalafil 40 mg arm	EG0001 events1 affected357 at risk
Haematoma	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Haemorrhage	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Hypertension	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Hypertensive crisis	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Hypotension	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0002 events2 affected357 at risk
Paradoxical embolism	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk
Thrombosis	Vascular disorders	MedDRA(13)	Systematic Assessment		EG0001 events1 affected357 at risk

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D026121	Indole Alkaloids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006575	Heterocyclic Compounds, 3-Ring