ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00312377
First received: April 6, 2006
Last updated: October 5, 2012
Last verified: October 2012
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Non-small Cell Lung Cancer
Lung Cancer
Interventions: Drug: Docetaxel
Drug: Vandetanib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled 08 May 2006, last patient enrolled 14 March 2008, cut off date 22 August 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vandetanib 100 mg Plus Docetaxel Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Placebo Plus Docetaxel Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles

Participant Flow:   Overall Study
    Vandetanib 100 mg Plus Docetaxel     Placebo Plus Docetaxel  
STARTED     694 [1]   697 [1]
COMPLETED     50 [2]   29 [2]
NOT COMPLETED     644     668  
Death                 403                 418  
Withdrawal by Subject                 23                 30  
Lost to Follow-up                 9                 12  
Non-compliance                 0                 2  
Randomised but never received treatment                 6                 6  
Discontinue treatment survival follow up                 202                 200  
Site ended participation in study                 1                 0  
[1] randomised patients
[2] ongoing study treatment at data cut-off



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vandetanib 100 mg Plus Docetaxel Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel Placebo plus docetaxel
Total Total of all reporting groups

Baseline Measures
    Vandetanib 100 mg Plus Docetaxel     Placebo Plus Docetaxel     Total  
Number of Participants  
[units: participants]
  694     697     1391  
Age  
[units: years]
Mean ( Full Range )
  58.5  
  ( 28 to 82 )  
  58.4  
  ( 20 to 82 )  
  58.45  
  ( 20 to 82 )  
Gender  
[units: Participants]
     
Female     497     473     970  
Male     197     224     421  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS) in the Overall Population   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months ]

2.  Primary:   Progression-Free Survival (PFS) in the Female Population   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months ]

3.  Secondary:   Overall Survival (OS) in the Overall Population   [ Time Frame: Time to death in months ]

4.  Secondary:   Overall Survival (OS) in the Female Population   [ Time Frame: Time to death in months ]

5.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

6.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

7.  Secondary:   Duration of Response (DoR)   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

8.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).   [ Time Frame: FACT-L questionnaires are to be administered every 3 weeks after randomisation ]

9.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)   [ Time Frame: FACT-L questionnaires are to be administered every 3 weeks after randomisation ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Vandetanib 100 mg Plus Docetaxel Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel Placebo plus docetaxel

Serious Adverse Events
    Vandetanib 100 mg Plus Docetaxel     Placebo Plus Docetaxel  
Total, serious adverse events      
# participants affected / at risk     263/694 (37.90%)     232/697 (33.29%)  
Blood and lymphatic system disorders      
Febrile Neutropenia † 1    
# participants affected / at risk     46/694 (6.63%)     38/697 (5.45%)  
Neutropenia † 1    
# participants affected / at risk     16/694 (2.31%)     18/697 (2.58%)  
Anaemia † 1    
# participants affected / at risk     4/694 (0.58%)     6/697 (0.86%)  
Leukopenia † 1    
# participants affected / at risk     3/694 (0.43%)     2/697 (0.29%)  
Leukocytosis † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Bone Marrow Failure † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Febrile Bone Marrow Aplasia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Iron Deficiency Anaemia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Cardiac disorders      
Atrial Fibrillation † 1    
# participants affected / at risk     3/694 (0.43%)     10/697 (1.43%)  
Myocardial Infarction † 1    
# participants affected / at risk     0/694 (0.00%)     4/697 (0.57%)  
Cardiac Arrest † 1    
# participants affected / at risk     1/694 (0.14%)     3/697 (0.43%)  
Cardiac Failure † 1    
# participants affected / at risk     0/694 (0.00%)     3/697 (0.43%)  
Acute Myocardial Infarction † 1    
# participants affected / at risk     2/694 (0.29%)     2/697 (0.29%)  
Atrial Flutter † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Angina Unstable † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Arrhythmia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Atrioventricular Block Complete † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Atrioventricular Block Second Degree † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Cardiac Tamponade † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Cardio-Respiratory Arrest † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Extrasystoles † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Pericardial Effusion † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Pericarditis † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Supraventricular Tachycardia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Tachyarrhythmia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Tachycardia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Ventricular Extrasystoles † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Congenital, familial and genetic disorders      
Hereditary Angioedema † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Ear and labyrinth disorders      
Deafness Unilateral † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Vertigo † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Eye disorders      
Ocular Surface Disease † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Retinal Artery Occlusion † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     14/694 (2.02%)     11/697 (1.58%)  
Vomiting † 1    
# participants affected / at risk     7/694 (1.01%)     8/697 (1.15%)  
Nausea † 1    
# participants affected / at risk     5/694 (0.72%)     4/697 (0.57%)  
Abdominal Pain Upper † 1    
# participants affected / at risk     4/694 (0.58%)     1/697 (0.14%)  
Constipation † 1    
# participants affected / at risk     0/694 (0.00%)     3/697 (0.43%)  
Gastric Ulcer † 1    
# participants affected / at risk     0/694 (0.00%)     3/697 (0.43%)  
Abdominal Pain † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Gastrointestinal Haemorrhage † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Stomatitis † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Appendicitis Perforated † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Ascites † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Dyspepsia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Dysphagia † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Enteritis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Enterocolitis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Gastric Haemorrhage † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Gastritis † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Gastrointestinal Inflammation † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Haematochezia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Ileus Paralytic † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Inguinal Hernia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Intestinal Obstruction † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Lower Gastrointestinal Haemorrhage † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Oesophageal Fistula † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Oesophageal Stenosis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Proctitis Haemorrhagic † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Upper Gastrointestinal Haemorrhage † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     13/694 (1.87%)     12/697 (1.72%)  
Asthenia † 1    
# participants affected / at risk     2/694 (0.29%)     5/697 (0.72%)  
Chest Pain † 1    
# participants affected / at risk     3/694 (0.43%)     0/697 (0.00%)  
Malaise † 1    
# participants affected / at risk     3/694 (0.43%)     0/697 (0.00%)  
Performance Status Decreased † 1    
# participants affected / at risk     3/694 (0.43%)     0/697 (0.00%)  
Fatigue † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
General Physical Health Deterioration † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Mucosal Inflammation † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Chills † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Death † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Multi-Organ Failure † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Pain † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Sudden Death † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Systemic Inflammatory Response Syndrome † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Immune system disorders      
Anaphylactic Shock † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Drug Hypersensitivity † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     33/694 (4.76%)     26/697 (3.73%)  
Respiratory Tract Infection † 1    
# participants affected / at risk     5/694 (0.72%)     6/697 (0.86%)  
Sepsis † 1    
# participants affected / at risk     5/694 (0.72%)     5/697 (0.72%)  
Upper Respiratory Tract Infection † 1    
# participants affected / at risk     0/694 (0.00%)     5/697 (0.72%)  
Gastroenteritis † 1    
# participants affected / at risk     4/694 (0.58%)     3/697 (0.43%)  
Lung Infection † 1    
# participants affected / at risk     4/694 (0.58%)     2/697 (0.29%)  
Urinary Tract Infection † 1    
# participants affected / at risk     4/694 (0.58%)     3/697 (0.43%)  
Lower Respiratory Tract Infection † 1    
# participants affected / at risk     3/694 (0.43%)     1/697 (0.14%)  
Septic Shock † 1    
# participants affected / at risk     3/694 (0.43%)     1/697 (0.14%)  
Bacterial Infection † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Bronchopneumonia † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Infection † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Neutropenic Infection † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Urosepsis † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Appendicitis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Bacteraemia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Bacterial Sepsis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Bronchopulmonary Aspergillosis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Catheter Related Infection † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Cellulitis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Central Line Infection † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Diverticulitis † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Empyema † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Epiglottitis † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Gastrointestinal Infection † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Infective Exacerbation Of Chronic Obstructive Airways Disease † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Infective Myositis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Lobar Pneumonia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Lung Abscess † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Oesophageal Candidiasis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Perianal Abscess † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pneumocystis Jiroveci Pneumonia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Pneumonia Streptococcal † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pyothorax † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Rash Pustular † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Rectal Abscess † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Respiratory Tract Infection Bacterial † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Skin Bacterial Infection † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Staphylococcal Infection † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Tuberculosis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Injury, poisoning and procedural complications      
Femur Fracture † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Humerus Fracture † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Brain Contusion † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Facial Bones Fracture † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Foot Fracture † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Hip Fracture † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Lower Limb Fracture † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Multiple Fractures † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Radiation Pneumonitis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Skin Laceration † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Skull Fracture † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Weight Decreased † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
White Blood Cell Count Decreased † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Alanine Aminotransferase Increased † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Aspartate Aminotransferase Increased † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Blood Alkaline Phosphatase Increased † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Blood Pressure Orthostatic Decreased † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Electrocardiogram T Wave Abnormal † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Neutrophil Count Decreased † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Metabolism and nutrition disorders      
Anorexia † 1    
# participants affected / at risk     3/694 (0.43%)     2/697 (0.29%)  
Dehydration † 1    
# participants affected / at risk     1/694 (0.14%)     3/697 (0.43%)  
Hyperkalaemia † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Hypoglycaemia † 1    
# participants affected / at risk     2/694 (0.29%)     2/697 (0.29%)  
Hyponatraemia † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Diabetes Mellitus † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Failure To Thrive † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Hypercalcaemia † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Hyperglycaemia † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Hypokalaemia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Type 2 Diabetes Mellitus † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Musculoskeletal and connective tissue disorders      
Back Pain † 1    
# participants affected / at risk     2/694 (0.29%)     4/697 (0.57%)  
Musculoskeletal Chest Pain † 1    
# participants affected / at risk     3/694 (0.43%)     4/697 (0.57%)  
Arthralgia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Bone Pain † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Flank Pain † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Muscular Weakness † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Musculoskeletal Pain † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Myalgia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pain In Extremity † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Tumour Pain † 1    
# participants affected / at risk     2/694 (0.29%)     2/697 (0.29%)  
Metastatic Pain † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Myelodysplastic Syndrome † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Nervous system disorders      
Convulsion † 1    
# participants affected / at risk     4/694 (0.58%)     1/697 (0.14%)  
Dizziness † 1    
# participants affected / at risk     3/694 (0.43%)     4/697 (0.57%)  
Headache † 1    
# participants affected / at risk     1/694 (0.14%)     3/697 (0.43%)  
Loss Of Consciousness † 1    
# participants affected / at risk     3/694 (0.43%)     1/697 (0.14%)  
Somnolence † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Syncope † 1    
# participants affected / at risk     2/694 (0.29%)     2/697 (0.29%)  
Altered State Of Consciousness † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Ataxia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Brachial Plexopathy † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Cauda Equina Syndrome † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Cerebral Haemorrhage † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Cerebral Infarction † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Cerebral Ischaemia † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Cerebrovascular Accident † 1    
# participants affected / at risk     1/694 (0.14%)     1/697 (0.14%)  
Coma † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Coma Hepatic † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Dyskinesia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Hemiparesis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Ischaemic Stroke † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Paraplegia † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Peripheral Sensory Neuropathy † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Polyneuropathy † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Pyramidal Tract Syndrome † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Spinal Cord Compression † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Subarachnoid Haemorrhage † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Psychiatric disorders      
Mental Status Changes † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Anxiety † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Confusional State † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Delirium † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Psychotic Behaviour † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Suicidal Ideation † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Renal and urinary disorders      
Dysuria † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Renal Failure † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Haematuria † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Nephrolithiasis † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Renal Failure Acute † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea † 1    
# participants affected / at risk     22/694 (3.17%)     21/697 (3.01%)  
Interstitial Lung Disease † 1    
# participants affected / at risk     12/694 (1.73%)     6/697 (0.86%)  
Pulmonary Embolism † 1    
# participants affected / at risk     2/694 (0.29%)     8/697 (1.15%)  
Haemoptysis † 1    
# participants affected / at risk     5/694 (0.72%)     6/697 (0.86%)  
Respiratory Failure † 1    
# participants affected / at risk     5/694 (0.72%)     6/697 (0.86%)  
Pneumonitis † 1    
# participants affected / at risk     4/694 (0.58%)     5/697 (0.72%)  
Pneumothorax † 1    
# participants affected / at risk     1/694 (0.14%)     5/697 (0.72%)  
Pleural Effusion † 1    
# participants affected / at risk     4/694 (0.58%)     3/697 (0.43%)  
Chronic Obstructive Pulmonary Disease † 1    
# participants affected / at risk     0/694 (0.00%)     3/697 (0.43%)  
Cough † 1    
# participants affected / at risk     3/694 (0.43%)     0/697 (0.00%)  
Aspiration † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Epistaxis † 1    
# participants affected / at risk     0/694 (0.00%)     2/697 (0.29%)  
Hypoxia † 1    
# participants affected / at risk     2/694 (0.29%)     1/697 (0.14%)  
Pulmonary Haemorrhage † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Respiratory Distress † 1    
# participants affected / at risk     1/694 (0.14%)     2/697 (0.29%)  
Acute Respiratory Distress Syndrome † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Asthma † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Bronchospasm † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Cryptogenic Organising Pneumonia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Diaphragmatic Rupture † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Dyspnoea Exertional † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Hydropneumothorax † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Laryngeal Inflammation † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Lung Infiltration † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pleurisy † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pneumonia Aspiration † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Productive Cough † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pulmonary Alveolar Haemorrhage † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Pulmonary Oedema † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Respiratory Depression † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     15/694 (2.16%)     1/697 (0.14%)  
Photosensitivity Reaction † 1    
# participants affected / at risk     5/694 (0.72%)     0/697 (0.00%)  
Toxic Epidermal Necrolysis † 1    
# participants affected / at risk     4/694 (0.58%)     0/697 (0.00%)  
Dermatitis Exfoliative † 1    
# participants affected / at risk     3/694 (0.43%)     0/697 (0.00%)  
Stevens-Johnson Syndrome † 1    
# participants affected / at risk     3/694 (0.43%)     0/697 (0.00%)  
Drug Eruption † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Erythema † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Pruritus † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Rash Erythematous † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Toxic Skin Eruption † 1    
# participants affected / at risk     2/694 (0.29%)     0/697 (0.00%)  
Dermatitis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Erythema Multiforme † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Exfoliative Rash † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Palmar-Plantar Erythrodysaesthesia Syndrome † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Rash Maculo-Papular † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Skin Toxicity † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Telangiectasia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Vascular disorders      
Deep Vein Thrombosis † 1    
# participants affected / at risk     1/694 (0.14%)     6/697 (0.86%)  
Hypotension † 1    
# participants affected / at risk     5/694 (0.72%)     1/697 (0.14%)  
Peripheral Arterial Occlusive Disease † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Peripheral Ischaemia † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Shock † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Subclavian Vein Thrombosis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Superior Vena Caval Stenosis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Vasculitis † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Vena Cava Thrombosis † 1    
# participants affected / at risk     0/694 (0.00%)     1/697 (0.14%)  
Venous Thrombosis † 1    
# participants affected / at risk     1/694 (0.14%)     0/697 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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