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FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01721954
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : October 22, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer Metastatic
Interventions Drug: FOLFOX6m
Device: SIR-Spheres microspheres
Enrollment 209
Recruitment Details Between 01May2013&24Dec2014,209 patients were screened&randomised from 87centres in Australia, Belgium,France, Germany, Israel, Italy, Korea, New Zealand, Portugal, Singapore, Spain,Taiwan &the US. 209 patients randomized in the Intent to treat (ITT) population. 5 patients who did not receive study medication were not included in safety population.
Pre-assignment Details  
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

FOLFOX6m

Period Title: Overall Study
Started 105 104
Completed 35 35
Not Completed 70 69
Reason Not Completed
Death             58             64
Withdrawal by Subject             8             4
Adverse Event             2             0
Lost to Follow-up             2             1
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone Total
Hide Arm/Group Description

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

FOLFOX6m

Total of all reporting groups
Overall Number of Baseline Participants 105 104 209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 104 participants 209 participants
62.6  (11.28) 62.4  (10.06) 62.5  (10.66)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, Categorical Number Analyzed 105 participants 104 participants 209 participants
Below 65 years
60
  57.1%
57
  54.8%
117
  56.0%
Greater than or equal to 65 years
45
  42.9%
47
  45.2%
92
  44.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
Female
41
  39.0%
44
  42.3%
85
  40.7%
Male
64
  61.0%
60
  57.7%
124
  59.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
   7.6%
6
   5.8%
14
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   3.8%
2
   1.9%
6
   2.9%
White
88
  83.8%
93
  89.4%
181
  86.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   4.8%
3
   2.9%
8
   3.8%
WHO performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
0
61
  58.1%
53
  51.0%
114
  54.5%
1
44
  41.9%
50
  48.1%
94
  45.0%
Unknown
0
   0.0%
1
   1.0%
1
   0.5%
[1]
Measure Description:

(0) Able to carry out all normal activity without restriction

(1) Restricted in physically strenuous activity but ambulatory and able to carry out light work

Extra-hepatic Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
Yes 32 27 59
No 73 77 150
Liver Involvement %  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
<=25% 74 74 148
>25% 31 30 61
Tumor volume  
Mean (Standard Deviation)
Unit of measure:  Percentage of liver
Number Analyzed 105 participants 104 participants 209 participants
18.5  (17.77) 17.9  (16.18) 18.2  (16.96)
ITT bevacizumab  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 209 participants
Yes
87
  82.9%
87
  83.7%
174
  83.3%
No
18
  17.1%
17
  16.3%
35
  16.7%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS defined as the time interval between the date of randomization and the date of death from any cause.
Time Frame From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description:

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

FOLFOX6m

Overall Number of Participants Analyzed 105 104
Median (95% Confidence Interval)
Unit of Measure: months
25.9
(23.1 to 29.0)
25.0
(22.1 to 28.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection mFOLFOX6 Plus SIRT, mFOLFOX6 Alone
Comments The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description:

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

FOLFOX6m

Overall Number of Participants Analyzed 105 104
Median (95% Confidence Interval)
Unit of Measure: months
11.8
(10.3 to 14.5)
11.2
(9.4 to 12.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection mFOLFOX6 Plus SIRT, mFOLFOX6 Alone
Comments A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Estimation Comments [Not Specified]
Time Frame From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months.
Adverse Event Reporting Description

Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment.

Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants.

The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.

 
Arm/Group Title mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Hide Arm/Group Description

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

FOLFOX6m

All-Cause Mortality
mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   58/92 (63.04%)   64/112 (57.14%) 
Hide Serious Adverse Events
mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   47/92 (51.09%)   47/112 (41.96%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  10/92 (10.87%)  3/112 (2.68%) 
Neutropenia  1  2/92 (2.17%)  1/112 (0.89%) 
Pancytopenia  1  2/92 (2.17%)  0/112 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction  1  1/92 (1.09%)  0/112 (0.00%) 
Arteriospasm Coronary  1  1/92 (1.09%)  1/112 (0.89%) 
Cardiac Failure  1  0/92 (0.00%)  1/112 (0.89%) 
Cardiotoxicity  1  1/92 (1.09%)  0/112 (0.00%) 
Eye disorders     
Retinal Detachment  1  0/92 (0.00%)  1/112 (0.89%) 
Vitreous Haemorrhage  1  1/92 (1.09%)  0/112 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  9/92 (9.78%)  0/112 (0.00%) 
Abdominal Pain Upper  1  0/92 (0.00%)  1/112 (0.89%) 
Anal Fissure  1  0/92 (0.00%)  1/112 (0.89%) 
Colitis  1  0/92 (0.00%)  1/112 (0.89%) 
Diarrhoea  1  5/92 (5.43%)  5/112 (4.46%) 
Duodenal Perforation  1  1/92 (1.09%)  0/112 (0.00%) 
Duodenal Ulcer Haemorrhage  1  0/92 (0.00%)  1/112 (0.89%) 
Enterocolitis  1  1/92 (1.09%)  0/112 (0.00%) 
Gastric Ulcer  1  2/92 (2.17%)  0/112 (0.00%) 
Gastritis  1  1/92 (1.09%)  0/112 (0.00%) 
Gastrointestinal Haemorrhage  1  1/92 (1.09%)  0/112 (0.00%) 
Haematemesis  1  1/92 (1.09%)  0/112 (0.00%) 
Intestinal Obstruction  1  1/92 (1.09%)  2/112 (1.79%) 
Intestinal Perforation  1  0/92 (0.00%)  1/112 (0.89%) 
Large Intestinal Obstruction  1  0/92 (0.00%)  1/112 (0.89%) 
Large Intestine Perforation  1  0/92 (0.00%)  1/112 (0.89%) 
Nausea  1  1/92 (1.09%)  0/112 (0.00%) 
Neutropenic Colitis  1  0/92 (0.00%)  1/112 (0.89%) 
Pancreatitis  1  2/92 (2.17%)  0/112 (0.00%) 
Small Intestinal Obstruction  1  0/92 (0.00%)  1/112 (0.89%) 
Varices Oesophageal  1  0/92 (0.00%)  1/112 (0.89%) 
Vomiting  1  1/92 (1.09%)  1/112 (0.89%) 
Constipation  1  1/92 (1.09%)  0/112 (0.00%) 
General disorders     
Asthenia  1  1/92 (1.09%)  0/112 (0.00%) 
Chest Pain  1  1/92 (1.09%)  0/112 (0.00%) 
Fatigue  1  1/92 (1.09%)  0/112 (0.00%) 
General Physical Health Deterioration  1  2/92 (2.17%)  2/112 (1.79%) 
Malaise  1  1/92 (1.09%)  1/112 (0.89%) 
Mucosal Inflammation  1  2/92 (2.17%)  0/112 (0.00%) 
Pain  1  1/92 (1.09%)  0/112 (0.00%) 
Pyrexia  1  2/92 (2.17%)  3/112 (2.68%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/92 (1.09%)  0/112 (0.00%) 
Hepatic Cirrhosis  1  1/92 (1.09%)  0/112 (0.00%) 
Hepatic Failure  1  2/92 (2.17%)  0/112 (0.00%) 
Hyperbilirubinaemia  1  1/92 (1.09%)  0/112 (0.00%) 
Portal Hypertension  1  0/92 (0.00%)  1/112 (0.89%) 
Infections and infestations     
Abdominal Sepsis  1  0/92 (0.00%)  1/112 (0.89%) 
Anal Abscess  1  0/92 (0.00%)  1/112 (0.89%) 
Campylobacter Gastroenteritis  1  1/92 (1.09%)  0/112 (0.00%) 
Cellulitis  1  1/92 (1.09%)  0/112 (0.00%) 
Clostridium Difficile Infection  1  1/92 (1.09%)  0/112 (0.00%) 
Device Related Infection  1  1/92 (1.09%)  1/112 (0.89%) 
Device Related Sepsis  1  0/92 (0.00%)  1/112 (0.89%) 
Enteritis Infectious  1  0/92 (0.00%)  1/112 (0.89%) 
Enterococcal Sepsis  1  1/92 (1.09%)  0/112 (0.00%) 
Escherichia Sepsis  1  2/92 (2.17%)  0/112 (0.00%) 
Escherichia Urinary Tract Infection  1  1/92 (1.09%)  0/112 (0.00%) 
Infection  1  1/92 (1.09%)  1/112 (0.89%) 
Infusion Site Cellulitis  1  1/92 (1.09%)  0/112 (0.00%) 
Infusion Site Infection  1  0/92 (0.00%)  1/112 (0.89%) 
Lower Respiratory Tract Infection  1  1/92 (1.09%)  1/112 (0.89%) 
Lung Abscess  1  0/92 (0.00%)  1/112 (0.89%) 
Neutropenic Sepsis  1  1/92 (1.09%)  0/112 (0.00%) 
Pelvic Abscess  1  1/92 (1.09%)  0/112 (0.00%) 
Peritonitis  1  1/92 (1.09%)  0/112 (0.00%) 
Peritonitis Bacterial  1  1/92 (1.09%)  0/112 (0.00%) 
Pneumonia  1  6/92 (6.52%)  3/112 (2.68%) 
Pseudomonal Bacteraemia  1  1/92 (1.09%)  0/112 (0.00%) 
Rectal Abscess  1  1/92 (1.09%)  0/112 (0.00%) 
Respiratory Tract Infection  1  0/92 (0.00%)  1/112 (0.89%) 
Sepsis  1  2/92 (2.17%)  2/112 (1.79%) 
Skin Bacterial Infection  1  1/92 (1.09%)  0/112 (0.00%) 
Upper Respiratory Tract Infection  1  1/92 (1.09%)  0/112 (0.00%) 
Urinary Tract Infection  1  2/92 (2.17%)  2/112 (1.79%) 
Injury, poisoning and procedural complications     
Arterial Injury  1  1/92 (1.09%)  0/112 (0.00%) 
Gastrointestinal Stoma Complication  1  0/92 (0.00%)  2/112 (1.79%) 
Hip Fracture  1  1/92 (1.09%)  0/112 (0.00%) 
Intestinal Anastomosis Complication  1  0/92 (0.00%)  1/112 (0.89%) 
Thermal Burn  1  0/92 (0.00%)  1/112 (0.89%) 
Investigations     
C-Reactive Protein Increased  1  0/92 (0.00%)  1/112 (0.89%) 
White Blood Cell Count Decreased  1  1/92 (1.09%)  0/112 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  4/92 (4.35%)  0/112 (0.00%) 
Diabetic Complication  1  0/92 (0.00%)  1/112 (0.89%) 
Diabetic Ketoacidosis  1  0/92 (0.00%)  1/112 (0.89%) 
Hypercalcaemia  1  1/92 (1.09%)  0/112 (0.00%) 
Hyperglycaemia  1  0/92 (0.00%)  2/112 (1.79%) 
Hypokalaemia  1  1/92 (1.09%)  1/112 (0.89%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/92 (0.00%)  2/112 (1.79%) 
Groin Pain  1  0/92 (0.00%)  1/112 (0.89%) 
Muscle Haemorrhage  1  1/92 (1.09%)  0/112 (0.00%) 
Pain In Extremity  1  0/92 (0.00%)  1/112 (0.89%) 
Pathological Fracture  1  0/92 (0.00%)  1/112 (0.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases To Meninges  1  0/92 (0.00%)  1/112 (0.89%) 
Nervous system disorders     
Hepatic Encephalopathy  1  2/92 (2.17%)  0/112 (0.00%) 
Mental Impairment  1  1/92 (1.09%)  0/112 (0.00%) 
Presyncope  1  0/92 (0.00%)  1/112 (0.89%) 
Syncope  1  1/92 (1.09%)  1/112 (0.89%) 
Psychiatric disorders     
Acute Psychosis  1  1/92 (1.09%)  0/112 (0.00%) 
Confusional State  1  1/92 (1.09%)  2/112 (1.79%) 
Delirium  1  1/92 (1.09%)  1/112 (0.89%) 
Renal and urinary disorders     
Renal Failure Acute  1  0/92 (0.00%)  1/112 (0.89%) 
Renal Injury  1  0/92 (0.00%)  1/112 (0.89%) 
Urinary Retention  1  1/92 (1.09%)  0/112 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/92 (1.09%)  0/112 (0.00%) 
Dyspnoea  1  1/92 (1.09%)  1/112 (0.89%) 
Epistaxis  1  0/92 (0.00%)  1/112 (0.89%) 
Haemoptysis  1  0/92 (0.00%)  1/112 (0.89%) 
Pneumonia Aspiration  1  0/92 (0.00%)  1/112 (0.89%) 
Pneumonitis  1  0/92 (0.00%)  1/112 (0.89%) 
Pulmonary Embolism  1  5/92 (5.43%)  0/112 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer  1  1/92 (1.09%)  0/112 (0.00%) 
Vascular disorders     
Artery Dissection  1  1/92 (1.09%)  0/112 (0.00%) 
Deep Vein Thrombosis  1  0/92 (0.00%)  1/112 (0.89%) 
Jugular Vein Thrombosis  1  0/92 (0.00%)  1/112 (0.89%) 
Orthostatic Hypotensio  1  1/92 (1.09%)  1/112 (0.89%) 
Peripheral Artery Thrombosis  1  1/92 (1.09%)  0/112 (0.00%) 
Vena Cava Thrombosis  1  0/92 (0.00%)  1/112 (0.89%) 
1
Term from vocabulary, MedDRA version 16.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
mFOLFOX6 Plus SIRT mFOLFOX6 Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   92/92 (100.00%)   111/112 (99.11%) 
Blood and lymphatic system disorders     
Neutropenia  1  43/92 (46.74%)  46/112 (41.07%) 
Thrombocytopenia  1  39/92 (42.39%)  11/112 (9.82%) 
Anaemia  1  21/92 (22.83%)  15/112 (13.39%) 
Leukopenia  1  13/92 (14.13%)  10/112 (8.93%) 
Lymphopenia  1  6/92 (6.52%)  1/112 (0.89%) 
Eye disorders     
Lacrimation Increased  1  2/92 (2.17%)  6/112 (5.36%) 
Gastrointestinal disorders     
Nausea  1  46/92 (50.00%)  55/112 (49.11%) 
Diarrhoea  1  35/92 (38.04%)  59/112 (52.68%) 
Constipation  1  39/92 (42.39%)  45/112 (40.18%) 
Abdominal Pain  1  33/92 (35.87%)  24/112 (21.43%) 
Vomiting  1  24/92 (26.09%)  33/112 (29.46%) 
Stomatitis  1  21/92 (22.83%)  29/112 (25.89%) 
Abdominal Pain Upper  1  20/92 (21.74%)  12/112 (10.71%) 
Gastrooesophageal Reflux Disease  1  7/92 (7.61%)  14/112 (12.50%) 
Mouth Ulceration  1  4/92 (4.35%)  14/112 (12.50%) 
Abdominal Distension  1  9/92 (9.78%)  7/112 (6.25%) 
Rectal Haemorrhage  1  7/92 (7.61%)  7/112 (6.25%) 
Dry Mouth  1  3/92 (3.26%)  9/112 (8.04%) 
Ascites  1  9/92 (9.78%)  1/112 (0.89%) 
Dyspepsia  1  5/92 (5.43%)  5/112 (4.46%) 
Gastritis  1  5/92 (5.43%)  1/112 (0.89%) 
General disorders     
Fatigue  1  48/92 (52.17%)  49/112 (43.75%) 
Mucosal Inflammation  1  12/92 (13.04%)  23/112 (20.54%) 
Asthenia  1  15/92 (16.30%)  18/112 (16.07%) 
Pyrexia  1  17/92 (18.48%)  16/112 (14.29%) 
Oedema Peripheral  1  13/92 (14.13%)  6/112 (5.36%) 
Pain  1  3/92 (3.26%)  8/112 (7.14%) 
Chest Pain  1  1/92 (1.09%)  8/112 (7.14%) 
Infections and infestations     
Urinary Tract Infection  1  9/92 (9.78%)  10/112 (8.93%) 
Upper Respiratory Tract Infection  1  10/92 (10.87%)  8/112 (7.14%) 
Nasopharyngitis  1  2/92 (2.17%)  8/112 (7.14%) 
Bronchitis  1  1/92 (1.09%)  6/112 (5.36%) 
Injury, poisoning and procedural complications     
Contusion  1  5/92 (5.43%)  3/112 (2.68%) 
Fall  1  5/92 (5.43%)  2/112 (1.79%) 
Investigations     
Weight Decreased  1  29/92 (31.52%)  19/112 (16.96%) 
Neutrophil Count Decreased  1  7/92 (7.61%)  8/112 (7.14%) 
Weight Increased  1  5/92 (5.43%)  9/112 (8.04%) 
Platelet Count Decreased  1  9/92 (9.78%)  4/112 (3.57%) 
Aspartate Aminotransferase Increased  1  9/92 (9.78%)  2/112 (1.79%) 
Blood Alkaline Phosphatase Increased  1  6/92 (6.52%)  5/112 (4.46%) 
White Blood Cell Count Decreased  1  7/92 (7.61%)  4/112 (3.57%) 
Blood Bilirubin Increased  1  5/92 (5.43%)  3/112 (2.68%) 
Alanine Aminotransferase Increased  1  6/92 (6.52%)  1/112 (0.89%) 
Blood Albumin Decreased  1  5/92 (5.43%)  2/112 (1.79%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  25/92 (27.17%)  30/112 (26.79%) 
Hypokalaemia  1  11/92 (11.96%)  13/112 (11.61%) 
Dehydration  1  5/92 (5.43%)  7/112 (6.25%) 
Hypomagnesaemia  1  3/92 (3.26%)  9/112 (8.04%) 
Hyperglycaemia  1  5/92 (5.43%)  6/112 (5.36%) 
Hypoalbuminaemia  1  8/92 (8.70%)  3/112 (2.68%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  9/92 (9.78%)  14/112 (12.50%) 
Musculoskeletal Pain  1  5/92 (5.43%)  12/112 (10.71%) 
Pain In Extremity  1  13/92 (14.13%)  4/112 (3.57%) 
Arthralgia  1  3/92 (3.26%)  8/112 (7.14%) 
Muscle Spasms  1  3/92 (3.26%)  7/112 (6.25%) 
Nervous system disorders     
Neuropathy peripheral  1  54/92 (58.70%)  55/112 (49.11%) 
Peripheral sensory neuropathy  1  16/92 (17.39%)  29/112 (25.89%) 
Headache  1  13/92 (14.13%)  21/112 (18.75%) 
Paraesthesia  1  15/92 (16.30%)  19/112 (16.96%) 
Dysgeusia  1  17/92 (18.48%)  10/112 (8.93%) 
Dizziness  1  8/92 (8.70%)  6/112 (5.36%) 
Psychiatric disorders     
Insomnia  1  16/92 (17.39%)  15/112 (13.39%) 
Anxiety  1  8/92 (8.70%)  12/112 (10.71%) 
Renal and urinary disorders     
Dysuria  1  1/92 (1.09%)  6/112 (5.36%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  20/92 (21.74%)  27/112 (24.11%) 
Cough  1  12/92 (13.04%)  13/112 (11.61%) 
Dyspnoea  1  10/92 (10.87%)  12/112 (10.71%) 
Dysphonia  1  3/92 (3.26%)  10/112 (8.93%) 
Oropharyngeal Pain  1  3/92 (3.26%)  8/112 (7.14%) 
Rhinorrhoea  1  4/92 (4.35%)  7/112 (6.25%) 
Pulmonary Embolism  1  3/92 (3.26%)  7/112 (6.25%) 
Hiccups  1  7/92 (7.61%)  0/112 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaesthesia Syndrome  1  11/92 (11.96%)  19/112 (16.96%) 
Rash  1  13/92 (14.13%)  11/112 (9.82%) 
Alopecia  1  7/92 (7.61%)  15/112 (13.39%) 
Dry Skin  1  4/92 (4.35%)  11/112 (9.82%) 
Pruritus  1  2/92 (2.17%)  7/112 (6.25%) 
Vascular disorders     
Hypertension  1  15/92 (16.30%)  28/112 (25.00%) 
1
Term from vocabulary, MedDRA version 16.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janet Bell, M.B.A.
Organization: Sirtex Medical
Phone: + 888-474-7839 ext 710
EMail: jbell@sirtex.com
Layout table for additonal information
Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT01721954    
Other Study ID Numbers: STX0112
First Submitted: October 26, 2012
First Posted: November 6, 2012
Results First Submitted: August 12, 2019
Results First Posted: October 22, 2019
Last Update Posted: November 5, 2019