Study: NCT01696214

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: self-limiting viral infection
Frequency: 4 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: transient back pain
Frequency: 1 affected / 5 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: transient dry mouth
Frequency: 1 affected / 5 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: self-limiting viral infection
Frequency: 1 affected / 5 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: transient drowsiness
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: transient rash
Frequency: 1 affected / 5 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Social circumstances
Notes: motor vehicle accident with no serious injury
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: transient tachycardia
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: musculoskeletal headache
Frequency: 1 affected / 5 at risk

Adverse event: sprained finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: sprained finger, recovered without difficulty
Frequency: 1 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: transient lower extremity itching
Frequency: 1 affected / 5 at risk

Adverse event: asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant hospitalized overnight with asthma exacerbation. Study drug stopped while overnight hospitalization and continued with randomized study drug and completed double blind portion of study.
Frequency: 1 affected / 5 at risk

Adverse event: Death
Serious: yes
Organ System: Social circumstances
Notes: Participant in the run-out phase with open label Advair 100/50 and was found dead. Autopsy found cause of that to be due to Phencyclidine and Cocaine Toxicity
Frequency: 1 affected / 5 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: self-limiting viral infection
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: transient back pain
Frequency: 1 affected / 5 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: treated urinary tract infection with no recurrence
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: transient nausea
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: musculoskeletal headache
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: transient constipation
Frequency: 1 affected / 5 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Notes: transient viral
Frequency: 1 affected / 5 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: migraine headache
Frequency: 1 affected / 5 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: self-limiting viral infection
Frequency: 3 affected / 5 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: transient chest wall discomfort
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: transient nausea
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: transient diarrhea
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: transient tachycardia
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: musculoskeletal headache
Frequency: 1 affected / 5 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: stable keratosis
Frequency: 1 affected / 5 at risk

Adverse event: swollen hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: transient swollen hand
Frequency: 1 affected / 5 at risk