Effect of Roflumilast on Exacerbation Rate in Patients Wi... | NCT00297102

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Roflumilast	Active Comparator	500 mcg, once daily, oral administration in the morning	Drug: Roflumilast
Placebo	Placebo Comparator	once daily	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast	Drug	500 mcg, once daily, oral administration in the morning	Roflumilast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)	Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].	52 weeks treatment period

Secondary Outcomes

Measure	Description	Time Frame
Post-bronchodilator FEV1 [L]	Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
AstraZeneca AstraZeneca	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Altana Pharma/Nycomed Investigational Site		Fullerton	California	92385	United States
Altana Pharma/Nycomed Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19716960	Result	Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.
28419462	Derived	Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Roflumilast	500 mcg, once daily, oral administration in the morning
FG001	Placebo	once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00046± 8 OG0018± 8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).	0.0003	No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.	Mean Difference (Net)	39	Standard Error of the Mean	11	2-Sided	95	18	60				No	Superiority or Other

Primary

COPD Exacerbation Rate (Moderate or Severe)

Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].

ITT analysis.

Posted

Mean

95% Confidence Interval

exacerbations per patient per year

52 weeks treatment period

ID	Title	Description
OG000	Roflumilast	500 mcg, once daily, oral administration in the morning
OG001	Placebo	once daily

Units	Counts
Participants	OG000

Secondary

Post-bronchodilator FEV1 [L]

Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

ITT analysis. Number of participants analyzed = number of participants with data available.

Posted

Least Squares Mean

Standard Error

Change from baseline over 52 weeks of treatment

ID	Title	Description
OG000	Roflumilast	500 mcg, once daily, oral administration in the morning
OG001	Placebo	once daily

Units	Counts
Participants	OG000

Secondary

Time to Mortality Due to Any Reason

ITT analysis. Number of participants analyzed = number of participants who died.

Posted

Mean

Standard Deviation

days

52 weeks treatment period

ID	Title	Description
OG000	Roflumilast	500 mcg, once daily, oral administration in the morning
OG001	Placebo	once daily

Units	Counts
Participants	OG00017

Secondary

Natural Log-transformed C-reactive Protein (CRP)

Mean change from baseline to the last post randomization measurement in natural log-transformed CRP

ITT analysis. Number of participants analyzed = number of participants with data available.

Posted

Least Squares Mean

95% Confidence Interval

mg/L

Change from baseline to last post randomization measurement (52 weeks)

ID	Title	Description
OG000	Roflumilast	500 mcg, once daily, oral administration in the morning
OG001	Placebo	once daily

Units	Counts
Participants	OG000

Secondary

Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period

The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.

ITT analysis. Number of participants analyzed = number of participants with data available.

Posted

Least Squares Mean

Standard Error

scores on a scale

Change from baseline over 52 weeks of treatment

ID	Title	Description
OG000	Roflumilast	500 mcg, once daily, oral administration in the morning
OG001	Placebo	once daily

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Roflumilast	500 mcg, once daily, oral administration in the morning			144	769	232	769
EG001	Placebo	once daily			153	755	136	755

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00095 events70 affected769 at risk EG001108 events82 affected755 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events3 affected769 at risk EG0013 events3 affected755 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events2 affected769 at risk EG0012 events2 affected755 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0012 events2 affected755 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0013 events2 affected755 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected769 at risk EG0010 events0 affected755 at risk
Cardiac failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0014 events4 affected755 at risk
Angina pectoris	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0012 events2 affected755 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0012 events2 affected755 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0013 events3 affected755 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0013 events3 affected755 at risk
Angina unstable	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0010 events0 affected755 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0012 events2 affected755 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Cardiac arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Left ventricular failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Palpitations	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected769 at risk EG00113 events11 affected755 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0012 events2 affected755 at risk
Cellulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Bacteraemia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Chronic sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Clostridial infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Diverticulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Lobar pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Septic shock	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Wound sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events2 affected769 at risk EG0011 events1 affected755 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0012 events2 affected755 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0010 events0 affected755 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0010 events0 affected755 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0010 events0 affected755 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Flatulence	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Ileus	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Volvulus	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Syncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected769 at risk EG0014 events2 affected755 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0012 events2 affected755 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0012 events2 affected755 at risk
Carotid artery disease	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Convulsion	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Dizziness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Loss of consciousness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Parkinson's disease	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Partial seizures	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Sciatica	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected769 at risk EG0010 events0 affected755 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Cervix neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hypertensive crisis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0012 events1 affected755 at risk
Aortic aneurysm	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Arterial disorder	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Arterial restenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Haematoma	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Venous thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Sudden death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Asthenia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Chest discomfort	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Injection site inflammation	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Malaise	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Non-cardiac chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Chemical eye injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Muscoloskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0012 events1 affected755 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0012 events2 affected755 at risk
Acute psychosis	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Confusional state	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Panic attack	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Suicide attempt	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Haematuria	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Renal colic	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Blepharochalasis	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Glaucoma	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Retinal detachment	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Bronchoscopy	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Computerised tomogram thorax abnormal	Investigations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0012 events1 affected755 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0011 events1 affected755 at risk
Cataract operation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Adenomatous polyposis coli	Congenital, familial and genetic disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected769 at risk EG0011 events1 affected755 at risk
Physical assault	Social circumstances	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected769 at risk EG0010 events0 affected755 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG00076 events57 affected769 at risk EG00165 events50 affected755 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	non-serious	EG00041 events33 affected769 at risk EG00149 events39 affected755 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	non-serious	EG00072 events62 affected769 at risk EG00130 events26 affected755 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	non-serious	EG00044 events40 affected769 at risk EG00115 events15 affected755 at risk
Weight decreased	Investigations	MedDRA (11.0)	Systematic Assessment		EG00094 events92 affected769 at risk EG00124 events24 affected755 at risk

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Roflumilast	500 mcg, once daily, oral administration in the morning
BG001	Placebo	once daily
BG002	Total	Total of all reporting groups