We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086580
First Posted: July 8, 2004
Last Update Posted: March 13, 2014
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.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
Results First Submitted: June 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: B-Cell Chronic Lymphocytic Leukemia
Interventions: Biological: FluCAM [Fludara + Campath]
Biological: fludarabine phosphate

  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
Treatment was from initiation of study drug(s) to 4 weeks after last administration of study drug. Follow-up was for those without disease progression and ended upon disease progression or primary endpoint analysis whichever came first. Observation included those with disease progression who were observed for alternative rx and overall survival.

Reporting Groups
  Description
Combination Arm (FluCAM) Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Fludarabine Alone Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.

Participant Flow for 3 periods

Period 1:   Treatment Period
    Combination Arm (FluCAM)   Fludarabine Alone
STARTED   168   167 
Safety Population   164 [1]   165 [2] 
COMPLETED   103 [3]   107 [4] 
NOT COMPLETED   65   60 
Disease progression                9                8 
Unable to comply with protocol                3                1 
Withdrawal by Subject                7                8 
Physician Decision                13                7 
AE - not treatment related                7                7 
Toxicity - treatment related                15                15 
Anemia or thrombocytopenia                1                4 
Death                5                7 
Not specified                5                3 
[1] Four participants did not receive treatment
[2] Two participants did not receive treatment
[3] Finished 6 cycles of study drugs
[4] Finished 6 cycles of study drug

Period 2:   Follow-up Period
    Combination Arm (FluCAM)   Fludarabine Alone
STARTED   141   137 
COMPLETED   37   18 
NOT COMPLETED   104   119 
Disease progression                72                99 
Unable to comply with protocol                5                0 
Withdrawal by Subject                6                6 
Physician Decision                0                1 
AE - not related                1                0 
Death                13                7 
Not specified                7                6 

Period 3:   Observation Period
    Combination Arm (FluCAM)   Fludarabine Alone
STARTED   95   121 
COMPLETED   49   56 
NOT COMPLETED   46   65 
Unable to comply with protocol                1                1 
Withdrawal by Subject                4                2 
Death                33                55 
Not specified                8                7 



  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
Combination Arm (FluCAM) Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Fludarabine Alone Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Total Total of all reporting groups

Baseline Measures
   Combination Arm (FluCAM)   Fludarabine Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 168   167   335 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (9.25)   60.8  (9.34)   60.4  (9.29) 
Gender 
[Units: Participants]
     
Female   59   59   118 
Male   109   108   217 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   167   167   334 
Other   1   0   1 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 169.0  (8.88)   169.4  (9.30)   169.2  (9.08) 
Body Surface Area (BSA) 
[Units: Meters^2]
Mean (Standard Deviation)
 1.87  (0.213)   1.90  (0.218)   1.88  (0.216) 
Maximum Lymph Node Size [1] 
[Units: Participants]
     
<5 centimeters   134   136   270 
>= 5 centimeters   34   31   65 
[1] The number of participants whose largest lymph node by physical exam assessment during a baseline visit fell within two categories: <5 cm and >=5 cm. If there is no enlarged lymph node, then size is classified as <5 cm.
World Health Organization (WHO) Performance Status [1] 
[Units: Participants]
     
WHO Performance Status = 0   81   72   153 
WHO Performance Status = 1   87   95   182 
[1] Per protocol, all participants had a WHO performance status of 0 or 1. A WHO performance status of 0 is defined as "patient is able to carry out all normal activity without restriction," and status of 1 is "patient is ambulatory and capable of all self-care but unable to carry out any work; up and about more than 50% of waking hours."
Rai Stage Group [1] 
[Units: Participants]
     
Rai Stage 0   2   2   4 
Rai Stage I - II   104   102   206 
Rai Stage III - IV   62   63   125 
[1]

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis with lymphadenopathy, Rai Stage II: Lymphocytosis with hepatomegaly or splenomegaly, Rai Stage III: Lymphocytosis with anemia, Rai Stage IV: Lymphocytosis with thrombocytopenia.

Per protocol, the 4 participants with Rai Stage 0 were eligible for the study because they had Binet Stage A.

Binet Stage [1] 
[Units: Participants]
     
Binet Stage A   27   25   52 
Binet Stage B   89   89   178 
Binet Stage C   52   53   105 
[1]

Binet staging classifies CLL according to the number of lymphoid tissues involved, as well as the presence of low red blood cell count (anemia) or low number of blood platelets (thrombocytopenia).

Binet Stage A: fewer than three areas of enlarged lymphoid tissue. Enlarged lymph nodes of the neck, underarms, and groin, as well as the spleen, are each considered "one group," whether unilateral (one-sided) or bilateral (on both sides).

Binet Stage B: more than three areas of enlarged lymphoid tissue.

Binet Stage C: anemia plus thrombocytopenia (platelets <100 x 10^3/dL).

Disease Status [1] 
[Units: Participants]
     
Relapsed   101   101   202 
Refractory   67   66   133 
[1] Count of participants with refractory or relapsed disease at baseline (as reported by the investigator).
Summary of Prior Therapy by Type of Therapy [1] 
[Units: Participants]
     
Fludarabine-containing therapy   25   26   51 
Non-fludarabine-containing therapy   143   141   284 
[1] Count of participants who had prior therapy categorized by type of therapy: fludarabine-containing therapy or non-fludarabine-containing therapy.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment   [ Time Frame: Up to 6 years ]

2.  Secondary:   Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)   [ Time Frame: Up to 9 months ]

3.  Secondary:   Kaplan-Meier Estimates of Overall Survival Time   [ Time Frame: Up to 6 years ]

4.  Secondary:   Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)   [ Time Frame: Up to 6 years ]

5.  Secondary:   Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)   [ Time Frame: Up to 6 years ]

6.  Secondary:   Kaplan-Meier Estimates for Time to Alternative Therapy   [ Time Frame: Up to 6 years ]

7.  Secondary:   Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline   [ Time Frame: Day 0 (baseline) ]

8.  Secondary:   Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment   [ Time Frame: up to month 6 (end of treatment) ]

9.  Secondary:   Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline   [ Time Frame: Day 0 (baseline) ]

10.  Secondary:   Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment   [ Time Frame: up to month 6 (end of treatment) ]

11.  Secondary:   Summary of Participants With Adverse Experiences (AEs)   [ Time Frame: Up to 6 years ]

12.  Secondary:   Mean Systemic Clearance (CL) of Fludarabine   [ Time Frame: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion) ]

13.  Secondary:   Total Volume of Distribution (Vss) of Fludarabine   [ Time Frame: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion) ]

14.  Secondary:   Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)   [ Time Frame: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion) ]

15.  Secondary:   Maximum Plasma Concentration (Cmax) of Fludarabine   [ Time Frame: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion) ]

16.  Secondary:   Participants With Minimal Residual Disease (MRD)   [ Time Frame: up to 9 months ]

17.  Other Pre-specified:   Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II   [ Time Frame: Up to 6 years ]

18.  Other Pre-specified:   Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV   [ Time Frame: Up to 6 years ]

19.  Other Pre-specified:   Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II   [ Time Frame: Up to 6 years ]

20.  Other Pre-specified:   Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV   [ Time Frame: Up to 6 years ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame Up to 6 years
Additional Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Reporting Groups
  Description
Combination Arm (FluCAM) Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Fludarabine Alone Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.

Serious Adverse Events
    Combination Arm (FluCAM)   Fludarabine Alone
Total, Serious Adverse Events     
# participants affected / at risk   54/164 (32.93%)   41/165 (24.85%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   1/164 (0.61%)   6/165 (3.64%) 
Anaemia haemolytic autoimmune † 1     
# participants affected / at risk   2/164 (1.22%)   2/165 (1.21%) 
Autoimmune neutropenia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Autoimmune thrombocytopenia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Disseminated intravascular coagulation † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Febrile neutropenia † 1     
# participants affected / at risk   5/164 (3.05%)   7/165 (4.24%) 
Haemolytic anaemia † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Haemolytic uraemic syndrome † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Leukopenia † 1     
# participants affected / at risk   4/164 (2.44%)   1/165 (0.61%) 
Neutropenia † 1     
# participants affected / at risk   8/164 (4.88%)   2/165 (1.21%) 
Pancytopenia † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Thrombocytopenia † 1     
# participants affected / at risk   5/164 (3.05%)   1/165 (0.61%) 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Angina pectoris † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cardiac arrest † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cardiac failure † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Cardiogenic shock † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Cardiopulmonary failure † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cardiovascular insufficiency † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Left ventricular dysfunction † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pericardial effusion † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Supraventricular tachycardia † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Eye disorders     
Retinopathy † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Gastrointestinal disorders     
Anal fistula † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Colitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Diarrhoea † 1     
# participants affected / at risk   4/164 (2.44%)   0/165 (0.00%) 
Enterocolitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Femoral hernia, obstructive † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Gastritis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Gastrointestinal hypermotility † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Lower gastrointestinal haemorrhage † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Nausea † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pancreatitis acute † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Umbilical hernia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Vomiting † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Infusion related reaction † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Mucosal inflammation † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Multi-organ failure † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pyrexia † 1     
# participants affected / at risk   5/164 (3.05%)   1/165 (0.61%) 
Sudden cardiac death † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hepatobiliary disorders     
Hepatic failure † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hepatitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hepatitis cholestatic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hepatitis toxic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hepatotoxicity † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Immune system disorders     
Hypogammaglobulinaemia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Infections and infestations     
Bronchitis † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Cellulitis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Cytomegalovirus infection † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Erysipelas † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Eye infection toxoplasmal † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Fungaemia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Gastroenteritis escherichia coli † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hepatitis c † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Herpes simplex † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Herpes zoster † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Infection † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Oral fungal infection † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Orchitis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Oropharyngeal candidiasis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Peritonsillar abscess † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pharyngitis † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Pharyngitis bacterial † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pneumococcal sepsis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pneumocystis jiroveci infection † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pneumocystis jiroveci pneumonia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pneumonia † 1     
# participants affected / at risk   5/164 (3.05%)   1/165 (0.61%) 
Pneumonia bacterial † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pneumonia fungal † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Pneumonia streptococcal † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pyelonephritis acute † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Respiratory tract infection † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Salmonella sepsis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Sepsis † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Septic shock † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Sinusitis † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Tonsillitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Tuberculosis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Investigations     
Cd4 lymphocytes decreased † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cytomegalovirus test positive † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Pneumocystis test positive † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Transaminases increased † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypokalaemia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Tumour lysis syndrome † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteochondrosis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Chronic lymphocytic leukaemia transformation † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Gastric cancer † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hodgkin's disease † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Malignant melanoma † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Malignant peritoneal neoplasm † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Malignant pleural effusion † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Neuroendocrine carcinoma of the skin † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Rectosigmoid cancer † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Nervous system disorders     
Brain oedema † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Cerebrovascular accident † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Coma hepatic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Ischaemic cerebral infarction † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Neuropathy peripheral † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Peripheral sensory neuropathy † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Radicular pain † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Renal and urinary disorders     
Calculus urinary † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cystitis haemorrhagic † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Nephrolithiasis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Renal failure † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Renal failure acute † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Acute respiratory failure † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Bronchospasm † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pulmonary oedema † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Dermatitis exfoliative † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pruritus † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Urticaria † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypertension † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0




  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