Study: NCT00571701

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient withdrew during 1st study period, died of pulmonary pneumonia secondary to RRP associated lung cancer 3 months after her last dose of study drug
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pneumonia resulting in inpatient hospitalization, 2 subjects had known pulmonary RRP and third patient had a tracheotomy
Frequency: 2 affected / 40 at risk

Adverse event: palpable lymph node
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Patient with long-history of pulmonary RRP found to have palpable lymph node- needle biopsy revealed atypical findings and additional findings confirmed metastatic RRP associated lung cancer
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes AEs reported as abdominal discomfort, abdominal pain, abdominal pain upper, dyspepsia, flatulence, gastritis and stomach infection
Frequency: 4 affected / 40 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: non-cardiac chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term includes cough, chest discomfort
Frequency: 4 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE terms include increased nasal secretions, rhinitis, strep infection, croup and sinusitis
Frequency: 7 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: elevated temperature
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pneumonia resulting in inpatient hospitalization, 2 subjects had known pulmonary RRP and third patient had a tracheotomy
Frequency: 1 affected / 39 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Resulted in inpatient hospitalization for this patient due to dehydration secondary to diarrhea and vomiting as a result of the influenza
Frequency: 1 affected / 39 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes AEs reported as abdominal discomfort, abdominal pain, abdominal pain upper, dyspepsia, flatulence, gastritis and stomach infection
Frequency: 5 affected / 39 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: non-cardiac chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE term includes cough, chest discomfort
Frequency: 4 affected / 39 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE terms include increased nasal secretions, rhinitis, strep infection, croup and sinusitis
Frequency: 9 affected / 39 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: elevated temperature
Frequency: 5 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk