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A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

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ClinicalTrials.gov Identifier: NCT00475423
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Thrombocytopenic Purpura
Intervention Drug: rituximab [MabThera/Rituxan]
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab
Hide Arm/Group Description Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
Period Title: Overall Study
Started 122
Completed 90
Not Completed 32
Reason Not Completed
Protocol Violation             5
Adverse Event             4
Withdrawal by Subject             6
Lack of Efficacy             8
Death             1
Reason not specified             1
Lost to Follow-up             7
Arm/Group Title Rituximab
Hide Arm/Group Description Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Baseline Participants 122
Hide Baseline Analysis Population Description
Safety population: all participants who received at least one dose of study medication and for whom follow-up safety information was available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants
49.5  (18.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants
Female
70
  57.4%
Male
52
  42.6%
1.Primary Outcome
Title Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
Hide Description Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10^9/L within 7 days prior to 1st rituximab infusion.
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.5
(34.0 to 53.4)
2.Secondary Outcome
Title Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
Hide Description Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
9.3
(4.5 to 16.4)
PR
34.3
(25.4 to 44.0)
MR
17.6
(10.9 to 26.1)
3.Secondary Outcome
Title Percentage of Participants Who Achieved CR
Hide Description CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
27.8
4.Secondary Outcome
Title Time to CR
Hide Description Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(305.0 to NA)
[1]
Median time to CR and upper limit of the 95% confidence interval could not determined due to an insufficient number of events.
5.Secondary Outcome
Title Percentage of Participants Who Achieved PR
Hide Description PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
56.5
6.Secondary Outcome
Title Time to PR
Hide Description Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Median (95% Confidence Interval)
Unit of Measure: days
53.0
(36.0 to 152.0)
7.Secondary Outcome
Title Percentage of Participants Who Achieved MR
Hide Description MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
71.3
8.Secondary Outcome
Title Time to MR
Hide Description Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Median (95% Confidence Interval)
Unit of Measure: days
22.0
(8.0 to 30.0)
9.Secondary Outcome
Title Percentage of Participants With Continued CR From Week 8 to Week 52
Hide Description The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 8 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population; only participants with a CR at Week 8 were included in the analysis.
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
10
10.Secondary Outcome
Title Duration of CR in Participants With Continued CR From Week 8 Until Week 52
Hide Description Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 8 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population; only participants with a CR at Week 8 were included in the analysis.
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Median and 95% confidence interval (CI) could not be calculated due an insufficient number of events.
11.Secondary Outcome
Title Duration of PR in Participants With Continued PR From Week 8 Until Week 52
Hide Description Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 8 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: days
247.0 [1] 
(219.0 to NA)
[1]
Upper limit of the 95% CI could not be calculated due to inadequate data.
12.Secondary Outcome
Title Duration of MR in Participants With Continued MR From Week 8 Until Week 52
Hide Description Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
Time Frame Week 8 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 66
Median (95% Confidence Interval)
Unit of Measure: days
256.0 [1] 
(168.0 to NA)
[1]
Upper limit of 95% CI could not be calculated due to inadequate data.
13.Secondary Outcome
Title Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event
Hide Description Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
50.0
14.Secondary Outcome
Title Time to Initiation of New ITP Therapy
Hide Description Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Median (95% Confidence Interval)
Unit of Measure: days
314.0 [1] 
(215.0 to NA)
[1]
Upper limit of the 95% CI could not be calculated due to censored or missing data.
15.Secondary Outcome
Title Percentage of Therapeutic Responders
Hide Description Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Week 26 43.5
Week 52 35.2
16.Secondary Outcome
Title Percentage of Participants With a Therapeutic Response
Hide Description Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR Population
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage participants
Week 26: CR
38.0
(28.8 to 47.8)
Week 26: PR
5.6
(2.1 to 11.7)
Week 26: MR
0.0
(0.0 to 3.4)
Week 26: NR
56.5
(46.6 to 66.0)
Week 52: CR
35.2
(26.2 to 45.0)
Week 52: PR
0.0
(0.0 to 3.4)
Week 52: MR
0.0
(0.0 to 3.4)
Week 52: NR
64.8
(55.0 to 73.8)
17.Secondary Outcome
Title Cluster of Differentiation 19 (CD19) B Cell Count
Hide Description Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.
Time Frame Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 122
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Baseline (n=84) 0.27  (0.374)
Week 1 (n=3) 0.30  (0.251)
Week 3 (n=96) 0.01  (0.052)
Week 8 (n=89) 0.01  (0.033)
Follow-up Month 4 (n=57) 0.01  (0.029)
Follow-up Month 6 (n=79) 0.03  (0.041)
Follow-up Month 8 (n=57) 0.07  (0.085)
Follow-up Month 10 (n=48) 0.15  (0.315)
Follow-up Month 12 (n=70) 0.18  (0.289)
Last Day (n=101) 0.13  (0.252)
18.Secondary Outcome
Title Change From Baseline in CD19 B Cell Count
Hide Description Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.
Time Frame Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg IV on Days 1 and 15.
Overall Number of Participants Analyzed 122
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 3 (n=81) -0.23  (0.290)
Week 8 (n=75) -0.27  (0.393)
Follow-up Month 4 (n=47) -0.21  (0.217)
Follow-up Month 6 (n=63) -0.23  (0.367)
Follow-up Month 8 (n=44) -0.22  (0.412)
Follow-up Month 10 (n=39) -0.08  (0.207)
Follow-up Month 12 (n=55) -0.06  (0.409)
Last Day (n=84) -0.13  (0.389)
Time Frame Up to Week 52
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description Participants received rituximab 1000 mg IV on Days 1 and 15.
All-Cause Mortality
Rituximab 1000 mg
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Rituximab 1000 mg
Affected / at Risk (%)
Total   12/122 (9.84%) 
Blood and lymphatic system disorders   
Thrombocytopenia * 1  1/122 (0.82%) 
Febrile neutropenia * 1  1/122 (0.82%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/122 (0.82%) 
Infections and infestations   
Lower Respiratory Tract Infection * 1  1/122 (0.82%) 
Streptococcal Bacteraemia * 1  1/122 (0.82%) 
Pneumocystis jiroveci pneumonia * 1  1/122 (0.82%) 
Injury, poisoning and procedural complications   
Asbestosis * 1  1/122 (0.82%) 
Spinal Compression Fracture * 1  1/122 (0.82%) 
Spinal Fracture * 1  1/122 (0.82%) 
Subdural Haematoma * 1  1/122 (0.82%) 
Subdural Haemorrhage * 1  1/122 (0.82%) 
Investigations   
Platelet Count Decreased * 1  1/122 (0.82%) 
Musculoskeletal and connective tissue disorders   
Back Pain * 1  1/122 (0.82%) 
Osteoporosis * 1  1/122 (0.82%) 
Pain in Extremity * 1  1/122 (0.82%) 
Psychiatric disorders   
Stress * 1  1/122 (0.82%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure * 1  1/122 (0.82%) 
Vascular disorders   
Haemorrhage * 1  1/122 (0.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab 1000 mg
Affected / at Risk (%)
Total   62/122 (50.82%) 
Blood and lymphatic system disorders   
Lymphadenopathy * 1  1/122 (0.82%) 
Cardiac disorders   
Angina pectoris * 1  1/122 (0.82%) 
Palpitation * 1  1/122 (0.82%) 
Ear and labyrinth disorders   
Vertigo * 1  2/122 (1.64%) 
Ear haemorrhage * 1  1/122 (0.82%) 
Ear pain * 1  1/122 (0.82%) 
Eye disorders   
Eye pain * 1  1/122 (0.82%) 
Eye swelling * 1  1/122 (0.82%) 
Photophobia * 1  1/122 (0.82%) 
Vision blurred * 1  1/122 (0.82%) 
Gastrointestinal disorders   
Diarrhoea * 1  5/122 (4.10%) 
Gingival bleeding * 1  3/122 (2.46%) 
Vomiting * 1  3/122 (2.46%) 
Abdominal pain * 1  2/122 (1.64%) 
Gastrointestinal haemorrhage * 1  2/122 (1.64%) 
Gastrointestinal pain * 1  2/122 (1.64%) 
Abdominal distension * 1  1/122 (0.82%) 
Abdominal pain upper * 1  1/122 (0.82%) 
Gingival pain * 1  1/122 (0.82%) 
Haematochezia * 1  1/122 (0.82%) 
Melaena * 1  1/122 (0.82%) 
Nausea * 1  1/122 (0.82%) 
General disorders   
Fatigue * 1  7/122 (5.74%) 
Influenza like illness * 1  3/122 (2.46%) 
Pyrexia * 1  2/122 (1.64%) 
Chest pain * 1  1/122 (0.82%) 
Chills * 1  1/122 (0.82%) 
Ill-defined disorder * 1  1/122 (0.82%) 
Oedema peripheral * 1  1/122 (0.82%) 
Pain * 1  1/122 (0.82%) 
Hepatobiliary disorders   
Jaundice cholestatic * 1  1/122 (0.82%) 
Immune system disorders   
Hypersensitivity * 1  1/122 (0.82%) 
Seasonal allergy * 1  1/122 (0.82%) 
Serum sickness * 1  1/122 (0.82%) 
Infections and infestations   
Nasopharyngitis * 1  5/122 (4.10%) 
Upper respiratory tract infection * 1  4/122 (3.28%) 
Respiratory tract infection * 1  2/122 (1.64%) 
Bronchitis * 1  1/122 (0.82%) 
Ear infection * 1  1/122 (0.82%) 
Gastroenteritis * 1  1/122 (0.82%) 
Gastroenteritis viral * 1  1/122 (0.82%) 
Pharyngitis * 1  1/122 (0.82%) 
Pneumonia * 1  1/122 (0.82%) 
Urinary tract infection * 1  1/122 (0.82%) 
Viral infection * 1  1/122 (0.82%) 
Injury, poisoning and procedural complications   
Contusion * 1  9/122 (7.38%) 
Fall * 1  1/122 (0.82%) 
Incision site pain * 1  1/122 (0.82%) 
Transfusion reaction * 1  1/122 (0.82%) 
Investigations   
Platelet count decreased * 1  2/122 (1.64%) 
Intraocular pressure increased * 1  1/122 (0.82%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/122 (0.82%) 
Iron deficiency * 1  1/122 (0.82%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  3/122 (2.46%) 
Myalgia * 1  3/122 (2.46%) 
Arthritis * 1  1/122 (0.82%) 
Flank pain * 1  1/122 (0.82%) 
Joint stiffness * 1  1/122 (0.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Myelodysplastic syndrome * 1  1/122 (0.82%) 
Nervous system disorders   
Headache * 1  7/122 (5.74%) 
Dizziness * 1  2/122 (1.64%) 
Lethargy * 1  2/122 (1.64%) 
Cognitive disorder * 1  1/122 (0.82%) 
Dysgeusia * 1  1/122 (0.82%) 
Paraesthesia * 1  1/122 (0.82%) 
Presyncope * 1  1/122 (0.82%) 
Restless legs syndrome * 1  1/122 (0.82%) 
Somnolence * 1  1/122 (0.82%) 
Tremor * 1  1/122 (0.82%) 
Psychiatric disorders   
Depression * 1  1/122 (0.82%) 
Reproductive system and breast disorders   
Vaginal haemorrhage * 1  2/122 (1.64%) 
Breast haematoma * 1  1/122 (0.82%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain * 1  4/122 (3.28%) 
Epistaxis * 1  3/122 (2.46%) 
Cough * 1  1/122 (0.82%) 
Dyspnoea * 1  1/122 (0.82%) 
Rhinorrhoea * 1  1/122 (0.82%) 
Skin and subcutaneous tissue disorders   
Petechiae * 1  5/122 (4.10%) 
Rash * 1  5/122 (4.10%) 
Urticaria * 1  2/122 (1.64%) 
Pruritus * 1  1/122 (0.82%) 
Skin pruritic * 1  1/122 (0.82%) 
Skin exfoliation * 1  1/122 (0.82%) 
Vascular disorders   
Haemorrhage * 1  1/122 (0.82%) 
Hypertension * 1  2/122 (1.64%) 
Hot flush * 1  1/122 (0.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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 only after the first publication or presentation that involves the Overall Study. The 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: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00475423    
Other Study ID Numbers: ML20948
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: October 6, 2014
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015