Efficacy and Safety of LAS 34273 in Patients With Moderat... | NCT00358436

ID	Type	Description	Link
ACCLAIM II	Other Identifier	Almirall,S.A.
CT000742	Other Identifier	Almirall,S.A.

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aclidinium 200 μg once-daily	Experimental	Aclidinium bromide 200 μg once-daily by inhalation	Drug: Aclidinium bromide
Placebo	Placebo Comparator	Placebo by inhalation	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aclidinium bromide	Drug	Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks	Aclidinium 200 μg once-daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough FEV1 (L) at 28 Weeks on Treatment	Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks	28 weeks
Trough FEV1 (L) at 12 Weeks on Treatment	Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment	Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.	52 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Esther Garcia, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Almirall Investigational Sites#926		Jasper	Alabama	35501	United States
Almirall Investigational Sites#858

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21518460	Derived	Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.

Label	URL
Sponsor web site	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
FG001	Placebo	Placebo by inhalation

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

Arm/Group Information

ID	Title	Description
BG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
BG001	Placebo	Placebo by inhalation
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.1± 8.6 BG00165.2± 8.6 BG002

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000217 BG00180 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG000122 BG00142 BG002

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

Trough FEV1 (L) at 28 Weeks on Treatment

Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks

Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.

Posted

Least Squares Mean

Standard Error

Liters

28 weeks

ID	Title	Description
OG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
OG001	Placebo	Placebo by inhalation

Units	Counts
Participants	OG000594 OG001201

Title

Denominators

Categories

Title	Measurements
	OG0001.220± 0.008 OG0011.162± 0.014

Secondary

Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment

Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.

Posted

Median

95% Confidence Interval

Days

52 weeks

ID	Title	Description
OG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
OG001	Placebo	Placebo by inhalation

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment

Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score

Posted

Number

Percentage of Patients

52 weeks

ID	Title	Description
OG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
OG001	Placebo	Placebo by inhalation

Units	Counts
Participants	OG000

Primary

Trough FEV1 (L) at 12 Weeks on Treatment

Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks

Posted

Least Squares Mean

Standard Error

Liters

12 weeks

ID	Title	Description
OG000	Aclidinium 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
OG001	Placebo	Once daily administered via inhalation

Units	Counts
Participants	OG000

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	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation			62	600	445	600
EG001	Placebo	Placebo by inhalation			23	204	136	204

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Acute myocardial infection	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Angina pectoris	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0012 events2 affected204 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0011 events1 affected204 at risk
Atrial flutter	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0011 events1 affected204 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0012 events2 affected204 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Lobar pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment		EG0003 events3 affected600 at risk EG0010 events0 affected204 at risk
Myocardial infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0005 events5 affected600 at risk EG0011 events1 affected204 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0011 events1 affected204 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (9.1)	Systematic Assessment		EG0003 events2 affected600 at risk EG0011 events1 affected204 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	Two patients, one in each group, reported pneumonia that was considered to be a non-treatment-emergent SAE experienced after discontinuation of study medication.	EG0005 events5 affected600 at risk EG0013 events3 affected204 at risk
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0012 events2 affected204 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	One patient in the placebo group experienced respiratory failure that was a non-treatment emergent SAE experienced after discontinuation of study medication.	EG0002 events2 affected600 at risk EG0012 events2 affected204 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0011 events1 affected204 at risk
Syncope	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0012 events2 affected204 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0002 events2 affected600 at risk EG0010 events0 affected204 at risk
Angina unstable	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Cardiac failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Retinal detachment	Eye disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Ileus	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Volvulus	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Chest pain	General disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Condition aggravated	General disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Appendicitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Bronchitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Pneumonia Haemophilus	Infections and infestations	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Rickettsiosis	Infections and infestations	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Urosepsis	Infections and infestations	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Multiple drug overdose	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Open fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Ulnar fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Gastrointerstinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Cerebellar infarction	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Cerebral infarction	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Convulsion	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Myelopathy	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Presycope	Nervous system disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Anxiety	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Renal failure	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Scleroderma renal crisis	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Bullous lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Angioneurotic oedema	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment		EG0001 events1 affected600 at risk EG0010 events0 affected204 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Hypotension	Vascular disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment		EG0000 events0 affected600 at risk EG0011 events1 affected204 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG00085 affected600 at risk EG00126 affected204 at risk
Nasopharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00076 affected600 at risk EG00123 affected204 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00065 affected600 at risk EG00120 affected204 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG00042 affected600 at risk EG0018 affected204 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG00040 affected600 at risk EG00115 affected204 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00029 affected600 at risk EG00110 affected204 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG00029 affected600 at risk EG0018 affected204 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00027 affected600 at risk EG0016 affected204 at risk
Sinusitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG00027 affected600 at risk EG0019 affected204 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG00025 affected600 at risk EG00111 affected204 at risk

Ancestor Terms

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