Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00471146
First received: May 7, 2007
Last updated: June 14, 2012
Last verified: June 2012
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Carcinoma, Pancreatic Ductal
Interventions: Drug: AG-013736
Drug: Gemcitabine
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Participant Flow:   Overall Study
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
STARTED     314     316  
Treated     305     308  
COMPLETED     142     142  
NOT COMPLETED     172     174  
Adverse Event                 32                 33  
Withdrawal by Subject                 14                 11  
Death                 11                 12  
Lost to Follow-up                 4                 2  
Protocol Violation                 2                 2  
Objective progression or relapse                 84                 87  
Global deterioration of health status                 12                 14  
Randomized but not treated                 9                 8  
Unspecified                 4                 5  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Axitinib + Gemcitabine     Placebo + Gemcitabine     Total  
Number of Participants  
[units: participants]
  314     316     630  
Age, Customized  
[units: Participants]
     
Less than 65 years     203     179     382  
Greater than or equal to 65 years     111     137     248  
Gender  
[units: Participants]
     
Female     123     128     251  
Male     191     188     379  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline until disease progression or at least 1 year after the randomization of last participant ]

3.  Secondary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline, every 8 weeks until tumor progression or death ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]

5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

6.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

7.  Secondary:   Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

8.  Secondary:   Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

9.  Secondary:   Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

10.  Secondary:   Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)   [ Time Frame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Serious Adverse Events
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Total, serious adverse events      
# participants affected / at risk     108/304 (35.53%)     102/309 (33.01%)  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     1/304 (0.33%)     4/309 (1.29%)  
Febrile neutropenia * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Neutropenia * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Splenic vein thrombosis * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Thrombocytopenia * 1    
# participants affected / at risk     2/304 (0.66%)     1/309 (0.32%)  
Cardiac disorders      
Acute myocardial infarction * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Angina pectoris * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Atrial fibrillation * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Cardiac arrest * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Cardiac failure * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Cardiac failure congestive * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Tachycardia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Congenital, familial and genetic disorders      
Pyloric stenosis * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Ear and labyrinth disorders      
Deafness * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Endocrine disorders      
Adrenal insufficiency * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Hypothyroidism * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Gastrointestinal disorders      
Abdominal discomfort * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Abdominal distension * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Abdominal pain * 1    
# participants affected / at risk     14/304 (4.61%)     10/309 (3.24%)  
Abdominal pain lower * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Abdominal pain upper * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Anal fistula * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Ascites * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Colonic obstruction * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Constipation * 1    
# participants affected / at risk     1/304 (0.33%)     5/309 (1.62%)  
Diarrhoea * 1    
# participants affected / at risk     2/304 (0.66%)     4/309 (1.29%)  
Duodenal obstruction * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Duodenal ulcer * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Dysphagia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Enterocutaneous fistula * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Gastrointestinal haemorrhage * 1    
# participants affected / at risk     2/304 (0.66%)     1/309 (0.32%)  
Gastrointestinal perforation * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Haematemesis * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Ileus * 1    
# participants affected / at risk     0/304 (0.00%)     3/309 (0.97%)  
Intestinal fistula * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Intestinal obstruction * 1    
# participants affected / at risk     2/304 (0.66%)     1/309 (0.32%)  
Intestinal perforation * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Large intestinal obstruction * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Large intestine perforation * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Melaena * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Nausea * 1    
# participants affected / at risk     7/304 (2.30%)     3/309 (0.97%)  
Obstruction gastric * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Pancreatitis acute * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Peritonitis * 1    
# participants affected / at risk     2/304 (0.66%)     1/309 (0.32%)  
Rectal haemorrhage * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Small intestinal haemorrhage * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Small intestinal perforation * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Subileus * 1    
# participants affected / at risk     2/304 (0.66%)     0/309 (0.00%)  
Vomiting * 1    
# participants affected / at risk     9/304 (2.96%)     11/309 (3.56%)  
General disorders      
Asthenia * 1    
# participants affected / at risk     8/304 (2.63%)     2/309 (0.65%)  
Chest pain * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Complication of device insertion * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Death * 1    
# participants affected / at risk     3/304 (0.99%)     1/309 (0.32%)  
Device dislocation * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Device occlusion * 1    
# participants affected / at risk     2/304 (0.66%)     2/309 (0.65%)  
Disease progression * 1    
# participants affected / at risk     9/304 (2.96%)     15/309 (4.85%)  
Drug interaction * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Fatigue * 1    
# participants affected / at risk     4/304 (1.32%)     0/309 (0.00%)  
General physical health deterioration * 1    
# participants affected / at risk     2/304 (0.66%)     3/309 (0.97%)  
Generalised oedema * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Impaired healing * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Mucosal inflammation * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Obstruction * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Oedema peripheral * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Pain * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Performance status decreased * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Pyrexia * 1    
# participants affected / at risk     13/304 (4.28%)     5/309 (1.62%)  
Hepatobiliary disorders      
Acholia * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Bile duct obstruction * 1    
# participants affected / at risk     2/304 (0.66%)     2/309 (0.65%)  
Cholangitis * 1    
# participants affected / at risk     7/304 (2.30%)     3/309 (0.97%)  
Cholecystitis acute * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Cholestasis * 1    
# participants affected / at risk     3/304 (0.99%)     0/309 (0.00%)  
Cytolytic hepatitis * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Gallbladder necrosis * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Hepatic function abnormal * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Hyperbilirubinaemia * 1    
# participants affected / at risk     1/304 (0.33%)     3/309 (0.97%)  
Jaundice * 1    
# participants affected / at risk     6/304 (1.97%)     4/309 (1.29%)  
Jaundice cholestatic * 1    
# participants affected / at risk     3/304 (0.99%)     2/309 (0.65%)  
Immune system disorders      
Contrast media allergy * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Infections and infestations      
Abdominal abscess * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Biliary tract infection * 1    
# participants affected / at risk     2/304 (0.66%)     0/309 (0.00%)  
Cellulitis * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Cytomegalovirus infection * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Device related infection * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Diverticulitis * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Ear infection * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Escherichia urinary tract infection * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Gastroenteritis * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Infection * 1    
# participants affected / at risk     1/304 (0.33%)     2/309 (0.65%)  
Peritoneal infection * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Pneumonia * 1    
# participants affected / at risk     2/304 (0.66%)     4/309 (1.29%)  
Respiratory tract infection * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Sepsis * 1    
# participants affected / at risk     1/304 (0.33%)     5/309 (1.62%)  
Septic shock * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Urinary tract infection * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Urinary tract infection fungal * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Urosepsis * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Injury, poisoning and procedural complications      
Drug dispensing error * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Fall * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Hand fracture * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Wrist fracture * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Investigations      
Alanine aminotransferase increased * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Aspartate aminotransferase increased * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Blood alkaline phosphatase increased * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Blood bilirubin increased * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Blood creatinine increased * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Haemoglobin decreased * 1    
# participants affected / at risk     1/304 (0.33%)     3/309 (0.97%)  
Liver function test abnormal * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Neutrophil count decreased * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Platelet count decreased * 1    
# participants affected / at risk     2/304 (0.66%)     1/309 (0.32%)  
White blood cell count decreased * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Metabolism and nutrition disorders      
Decreased appetite * 1    
# participants affected / at risk     7/304 (2.30%)     4/309 (1.29%)  
Dehydration * 1    
# participants affected / at risk     4/304 (1.32%)     4/309 (1.29%)  
Diabetes mellitus * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Hypercalcaemia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Hyperglycaemia * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Hypoalbuminaemia * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Hypoglycaemia * 1    
# participants affected / at risk     2/304 (0.66%)     0/309 (0.00%)  
Hypokalaemia * 1    
# participants affected / at risk     4/304 (1.32%)     1/309 (0.32%)  
Hyponatraemia * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Hypophagia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Malnutrition * 1    
# participants affected / at risk     2/304 (0.66%)     0/309 (0.00%)  
Tumour lysis syndrome * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Musculoskeletal and connective tissue disorders      
Arthralgia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Back pain * 1    
# participants affected / at risk     2/304 (0.66%)     2/309 (0.65%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Duodenal neoplasm * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Metastatic neoplasm * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Neoplasm progression * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Pancreatic carcinoma * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Tumour associated fever * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Tumour pain * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Nervous system disorders      
Cerebral ischaemia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Cerebrovascular accident * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Cognitive disorder * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Diabetic coma * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Dysgeusia * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Grand mal convulsion * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Psychomotor skills impaired * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Reversible posterior leukoencephalopathy syndrome * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Sensory disturbance * 1    
# participants affected / at risk     2/304 (0.66%)     0/309 (0.00%)  
Somnolence * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Syncope * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Thrombotic stroke * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Transient ischaemic attack * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Psychiatric disorders      
Agitation * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Anxiety * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Confusional state * 1    
# participants affected / at risk     4/304 (1.32%)     3/309 (0.97%)  
Depression * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Mental status changes * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Renal and urinary disorders      
Chromaturia * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Renal failure * 1    
# participants affected / at risk     3/304 (0.99%)     1/309 (0.32%)  
Renal failure acute * 1    
# participants affected / at risk     3/304 (0.99%)     3/309 (0.97%)  
Ureteric perforation * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Urethral obstruction * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Urinary incontinence * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea * 1    
# participants affected / at risk     2/304 (0.66%)     3/309 (0.97%)  
Hiccups * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Hypoxia * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Interstitial lung disease * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Pleural effusion * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Pneumonitis * 1    
# participants affected / at risk     1/304 (0.33%)     2/309 (0.65%)  
Pulmonary embolism * 1    
# participants affected / at risk     2/304 (0.66%)     6/309 (1.94%)  
Respiratory failure * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Skin and subcutaneous tissue disorders      
Erythema * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Rash * 1    
# participants affected / at risk     0/304 (0.00%)     2/309 (0.65%)  
Skin ulcer * 1    
# participants affected / at risk     1/304 (0.33%)     0/309 (0.00%)  
Vascular disorders      
Bleeding varicose vein * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Deep vein thrombosis * 1    
# participants affected / at risk     1/304 (0.33%)     3/309 (0.97%)  
Hypertension * 1    
# participants affected / at risk     1/304 (0.33%)     1/309 (0.32%)  
Hypotension * 1    
# participants affected / at risk     1/304 (0.33%)     2/309 (0.65%)  
Phlebitis * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Shock * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Venous thrombosis * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
Venous thrombosis limb * 1    
# participants affected / at risk     0/304 (0.00%)     1/309 (0.32%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA v13.1




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information