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Trial record 64 of 180 for:    ERYTHROMYCIN

A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

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ClinicalTrials.gov Identifier: NCT00718315
Recruitment Status : Completed
First Posted : July 18, 2008
Results First Posted : January 15, 2015
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: erlotinib [Tarceva]
Drug: fusidic acid [Verutex]
Drug: erythromycin [Eritex]
Drug: Fisiogel
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Period Title: Overall Study
Started 67 67 67
Completed 48 45 46
Not Completed 19 22 21
Reason Not Completed
Adverse Event             1             2             3
Death             6             6             5
Lost to Follow-up             2             3             4
Protocol Violation             5             5             3
Erlotinib dose decreased             4             3             1
Use of Minocyclin             1             1             1
Disease progression             0             1             1
Other             0             0             1
Use of ATB and Corticoids             0             1             2
Arm/Group Title Fisiogel Stiemicyn Verutex Total
Hide Arm/Group Description Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Total of all reporting groups
Overall Number of Baseline Participants 67 67 67 201
Hide Baseline Analysis Population Description
Intention to treat (ITT) population covered all participants who had at least one application of study drug and who had at least one post-treatment assessment, irrespective of compliance extent with protocol criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 67 participants 67 participants 201 participants
65.3  (11.1) 63.6  (11.0) 64.6  (14.0) 64.7  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 67 participants 201 participants
Female
37
  55.2%
31
  46.3%
26
  38.8%
94
  46.8%
Male
30
  44.8%
36
  53.7%
41
  61.2%
107
  53.2%
1.Primary Outcome
Title Percentage of Participants Who Develop Skin Rash
Hide Description Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line “Rash/desquamation” – short name “rash”).
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 65 65 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.0
(47.1 to 72.0)
69.2
(56.6 to 80.1)
73.1
(60.9 to 83.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.481
Comments Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test)
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stiemicyn
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test)
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test)
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Skin Rash Stratified by Severity Grade
Hide Description The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 57 60 60
Measure Type: Number
Unit of Measure: percentage of participants
Grade 0 29.8 25.0 18.3
Grade 1 21.1 18.3 43.3
Grade 2 49.1 56.7 35.0
Grade 3 0 0 3.3
Grade 4 0 0 0
Grade 5 0 0 0
3.Secondary Outcome
Title Time to Appearance of Skin Rash
Hide Description Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE
Time Frame Days 0, 15, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 65 65 67
Median (95% Confidence Interval)
Unit of Measure: Days
16.0
(15.0 to 28.0)
15.0
(15.0 to 16.0)
15.0
(14.0 to 15.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Erythema
Hide Description Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries
Time Frame Days 0, 15, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 67 67 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.7
(44.8 to 67.9)
56.7
(44.8 to 67.9)
43.3
(32.1 to 55.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Pruritus
Hide Description Pruritus is defined as intense localized itching
Time Frame Days 0, 15, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 61 63 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.1
(25.2 to 48.6)
47.6
(35.8 to 59.7)
29.5
(19.6 to 41.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Pain
Hide Description Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli
Time Frame Days 0, 15, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 67 67 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.4
(9.4 to 27.1)
25.4
(16.5 to 36.9)
13.4
(7.2 to 23.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Erythema Stratified by Severity Grade
Hide Description The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 61 63 61
Measure Type: Number
Unit of Measure: percentage of participants
Grade 0 37.7 39.7 52.5
Grade 1 39.3 36.5 39.3
Grade 2 23.0 22.2 6.6
Grade 3 0 1.6 1.6
Grade 4 0 0 0
Grade 5 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Pruritus Stratified by Severity Grade
Hide Description The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 61 63 61
Measure Type: Number
Unit of Measure: percentage of participants
Grade 0 63.9 52.4 70.5
Grade 1 19.7 31.7 24.6
Grade 2 14.8 14.3 3.3
Grade 3 1.6 1.6 1.6
Grade 4 0 0 0
Grade 5 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Pain Stratified by Severity Grade
Hide Description The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description:
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
Overall Number of Participants Analyzed 61 63 61
Measure Type: Number
Unit of Measure: percentage of participants
Grade 0 82.0 73.0 85.2
Grade 1 11.5 22.2 6.6
Grade 2 4.9 4.8 6.6
Grade 3 1.6 0 1.6
Grade 4 0 0 0
Grade 5 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fisiogel, Stiemicyn, Verutex
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fisiogel Stiemicyn Verutex
Hide Arm/Group Description Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
All-Cause Mortality
Fisiogel Stiemicyn Verutex
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fisiogel Stiemicyn Verutex
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/67 (17.91%)   13/66 (19.70%)   19/67 (28.36%) 
Cardiac disorders       
Pericardial effusion (non-malignant) * 1  1/67 (1.49%)  0/66 (0.00%)  0/67 (0.00%) 
Gastrointestinal disorders       
Ascites (non-malignant) * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
Obstruction, GI - small bowel NOS * 1  1/67 (1.49%)  0/66 (0.00%)  0/67 (0.00%) 
No specification * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
Vomiting * 1  0/67 (0.00%)  1/66 (1.52%)  0/67 (0.00%) 
Hemorrhage, GI, lower GI NOS * 1  1/67 (1.49%)  0/66 (0.00%)  0/67 (0.00%) 
Hemorrhage, GI, stomach * 1  0/67 (0.00%)  1/66 (1.52%)  0/67 (0.00%) 
General disorders       
Fatigue (asthenia, lethargy, malaise * 1  0/67 (0.00%)  2/66 (3.03%)  1/67 (1.49%) 
Fever (in the absence of neutropenia, where neurtropenia is defined as ANC <1.0x109/L) * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
No specification * 1  0/67 (0.00%)  1/66 (1.52%)  0/67 (0.00%) 
Infections and infestations       
Sepsis * 1  0/67 (0.00%)  1/66 (1.52%)  0/67 (0.00%) 
Lung (pneumonia) * 1  1/67 (1.49%)  1/66 (1.52%)  1/67 (1.49%) 
Pulmonary/upper respiratory * 1  0/67 (0.00%)  0/66 (0.00%)  3/67 (4.48%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death not associated with CTCAE term * 1  2/67 (2.99%)  3/66 (4.55%)  2/67 (2.99%) 
Death not associated with CTCAE term - "cardiac arrest" * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
Disease progression NOS * 1  1/67 (1.49%)  0/66 (0.00%)  1/67 (1.49%) 
Nervous system disorders       
CNS cerebrovascular ischemia * 1  1/67 (1.49%)  0/66 (0.00%)  0/67 (0.00%) 
Confusion * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
Renal and urinary disorders       
Renal failure * 1  1/67 (1.49%)  0/66 (0.00%)  0/67 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
Hemorrhage, pulmonary/upper respiratory, respiratory tract NOS * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
No specification, pulmonary/upper respiratory, pain * 1  0/67 (0.00%)  1/66 (1.52%)  1/67 (1.49%) 
Adult respiratory distress syndrome * 1  0/67 (0.00%)  2/66 (3.03%)  2/67 (2.99%) 
Dyspnea (shortness of breath) * 1  3/67 (4.48%)  2/66 (3.03%)  4/67 (5.97%) 
Pleural effusion (non-malignant) * 1  2/67 (2.99%)  0/66 (0.00%)  1/67 (1.49%) 
No specification * 1  0/67 (0.00%)  1/66 (1.52%)  3/67 (4.48%) 
Vascular disorders       
No specification, cardiovascular, pain * 1  0/67 (0.00%)  1/66 (1.52%)  0/67 (0.00%) 
Thrombosis/thrombus/embolism * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
Vessel injury - vein - SVC * 1  0/67 (0.00%)  0/66 (0.00%)  1/67 (1.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fisiogel Stiemicyn Verutex
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/67 (67.16%)   45/66 (68.18%)   48/67 (71.64%) 
Blood and lymphatic system disorders       
Hemoglobin * 1  0/67 (0.00%)  2/66 (3.03%)  2/67 (2.99%) 
Eye disorders       
Dry eye syndrome * 1  2/67 (2.99%)  0/66 (0.00%)  1/67 (1.49%) 
Gastrointestinal disorders       
Diarrhea * 1  15/67 (22.39%)  18/66 (27.27%)  14/67 (20.90%) 
Anorexia * 1  5/67 (7.46%)  7/66 (10.61%)  6/67 (8.96%) 
Nausea * 1  3/67 (4.48%)  4/66 (6.06%)  3/67 (4.48%) 
Mucositis/stomatitis (clinical exam) - oral cavity * 1  2/67 (2.99%)  5/66 (7.58%)  2/67 (2.99%) 
Vomiting * 1  2/67 (2.99%)  4/66 (6.06%)  0/67 (0.00%) 
Constipation * 1  1/67 (1.49%)  2/66 (3.03%)  2/67 (2.99%) 
Mucositis/stomatitis (functional/symptomatic) - oral cavity * 1  2/67 (2.99%)  1/66 (1.52%)  1/67 (1.49%) 
No specification * 1  0/67 (0.00%)  1/66 (1.52%)  3/67 (4.48%) 
Dry mouth/salivary gland (xerostomia) * 1  1/67 (1.49%)  2/66 (3.03%)  0/67 (0.00%) 
No specification * 1  2/67 (2.99%)  1/66 (1.52%)  1/67 (1.49%) 
General disorders       
Fatigue (asthenia, lethargy, malaise) * 1  9/67 (13.43%)  8/66 (12.12%)  4/67 (5.97%) 
Fever * 1  2/67 (2.99%)  1/66 (1.52%)  2/67 (2.99%) 
No specification * 1  3/67 (4.48%)  1/66 (1.52%)  2/67 (2.99%) 
Infections and infestations       
Lung (pneumonia) * 1  1/67 (1.49%)  1/66 (1.52%)  1/67 (1.49%) 
Pulmonary/upper respiratory * 1  1/67 (1.49%)  4/66 (6.06%)  6/67 (8.96%) 
Renal/genitourinary * 1  1/67 (1.49%)  0/66 (0.00%)  3/67 (4.48%) 
No specification * 1  1/67 (1.49%)  1/66 (1.52%)  2/67 (2.99%) 
Musculoskeletal and connective tissue disorders       
No specification * 1  1/67 (1.49%)  4/66 (6.06%)  1/67 (1.49%) 
No specification * 1  1/67 (1.49%)  1/66 (1.52%)  1/67 (1.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death not associated with CTCAE term * 1  2/67 (2.99%)  3/66 (4.55%)  2/67 (2.99%) 
Nervous system disorders       
Dizziness * 1  1/67 (1.49%)  2/66 (3.03%)  2/67 (2.99%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea (shortness of breath) * 1  6/67 (8.96%)  4/66 (6.06%)  4/67 (5.97%) 
Cough * 1  3/67 (4.48%)  7/66 (10.61%)  0/67 (0.00%) 
No specification * 1  2/67 (2.99%)  1/66 (1.52%)  4/67 (5.97%) 
Adult respiratory distress syndrome * 1  0/67 (0.00%)  2/66 (3.03%)  2/67 (2.99%) 
Pleural effusion (non-malignant) * 1  2/67 (2.99%)  0/66 (0.00%)  1/67 (1.49%) 
No specification * 1  0/67 (0.00%)  2/66 (3.03%)  2/67 (2.99%) 
Skin and subcutaneous tissue disorders       
No specification * 1  2/67 (2.99%)  1/66 (1.52%)  4/67 (5.97%) 
Dry skin * 1  1/67 (1.49%)  2/66 (3.03%)  3/67 (4.48%) 
Nail change * 1  0/67 (0.00%)  3/66 (4.55%)  0/67 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00718315     History of Changes
Other Study ID Numbers: ML21450
First Submitted: July 16, 2008
First Posted: July 18, 2008
Results First Submitted: January 9, 2015
Results First Posted: January 15, 2015
Last Update Posted: January 15, 2015