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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00086580
First received: July 6, 2004
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: June 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: B-Cell Chronic Lymphocytic Leukemia
Interventions: Biological: FluCAM [Fludara + Campath]
Biological: fludarabine phosphate

  Participant Flow
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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
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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


  Other Adverse Events
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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.

Frequency Threshold
Threshold above which other adverse events are reported   0  

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.

Other Adverse Events
    Combination Arm (FluCAM)   Fludarabine Alone
Total, other (not including serious) adverse events     
# participants affected / at risk   160/164 (97.56%)   147/165 (89.09%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   36/164 (21.95%)   39/165 (23.64%) 
Autoimmune thrombocytopenia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Eosinophilia † 1     
# participants affected / at risk   1/164 (0.61%)   3/165 (1.82%) 
Febrile neutropenia † 1     
# participants affected / at risk   1/164 (0.61%)   4/165 (2.42%) 
Granulocytopenia † 1     
# participants affected / at risk   3/164 (1.83%)   1/165 (0.61%) 
Haematotoxicity † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Idiopathic thrombocytopenic purpura † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Leukopenia † 1     
# participants affected / at risk   73/164 (44.51%)   25/165 (15.15%) 
Lymphopenia † 1     
# participants affected / at risk   35/164 (21.34%)   7/165 (4.24%) 
Neutropenia † 1     
# participants affected / at risk   82/164 (50.00%)   84/165 (50.91%) 
Pancytopenia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Thrombocytopenia † 1     
# participants affected / at risk   44/164 (26.83%)   44/165 (26.67%) 
Cardiac disorders     
Angina pectoris † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Aortic valve calcification † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Aortic valve incompetence † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Arrhythmia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Arteriosclerosis coronary artery † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Atrial fibrillation † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Cardiac failure † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cardiomyopathy † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Diastolic dysfunction † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypertensive cardiomyopathy † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypertensive heart disease † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Left ventricular dysfunction † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Mitral valve incompetence † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Myocardial ischaemia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Palpitations † 1     
# participants affected / at risk   1/164 (0.61%)   3/165 (1.82%) 
Pericardial effusion † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Sinus tachycardia † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Tachycardia † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Ventricular arrhythmia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Ventricular extrasystoles † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Congenital, familial and genetic disorders     
Accessory spleen † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Kidney malformation † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Ear and labyrinth disorders     
Deafness neurosensory † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Hearing impaired † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Tinnitus † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Vertigo † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Endocrine disorders     
Goitre † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Hypothyroidism † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Eye disorders     
Cataract † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Conjunctival haemorrhage † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Conjunctivitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Conjunctivitis allergic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Erythema of eyelid † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Lacrimation increased † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Retinopathy † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Retinopathy hypertensive † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Visual impairment † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Gastrointestinal disorders     
Abdominal discomfort † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Abdominal distension † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Abdominal pain † 1     
# participants affected / at risk   4/164 (2.44%)   3/165 (1.82%) 
Abdominal pain upper † 1     
# participants affected / at risk   0/164 (0.00%)   3/165 (1.82%) 
Aphthous stomatitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Ascites † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cheilitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Colitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Constipation † 1     
# participants affected / at risk   6/164 (3.66%)   4/165 (2.42%) 
Diarrhoea † 1     
# participants affected / at risk   15/164 (9.15%)   11/165 (6.67%) 
Diverticulum intestinal † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Dry mouth † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Duodenal ulcer † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Duodenitis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Dyspepsia † 1     
# participants affected / at risk   3/164 (1.83%)   3/165 (1.82%) 
Enterocolitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Erosive duodenitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Flatulence † 1     
# participants affected / at risk   2/164 (1.22%)   3/165 (1.82%) 
Gastric ulcer † 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%) 
Gastrooesophageal reflux disease † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Gingival bleeding † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Gingival pain † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Gingivitis ulcerative † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Haemorrhoids † 1     
# participants affected / at risk   3/164 (1.83%)   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   20/164 (12.20%)   13/165 (7.88%) 
Pancreatic disorder † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pancreatitis † 1     
# participants affected / at risk   3/164 (1.83%)   3/165 (1.82%) 
Pancreatitis acute † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Periodontitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Stomatitis † 1     
# participants affected / at risk   4/164 (2.44%)   0/165 (0.00%) 
Toothache † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Vomiting † 1     
# participants affected / at risk   15/164 (9.15%)   3/165 (1.82%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   4/164 (2.44%)   6/165 (3.64%) 
Catheter site inflammation † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Chest discomfort † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Chills † 1     
# participants affected / at risk   49/164 (29.88%)   2/165 (1.21%) 
Face oedema † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Fatigue † 1     
# participants affected / at risk   10/164 (6.10%)   9/165 (5.45%) 
Generalised oedema † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hyperpyrexia † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Hyperthermia † 1     
# participants affected / at risk   6/164 (3.66%)   0/165 (0.00%) 
Impaired healing † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Influenza like illness † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Infusion related reaction † 1     
# participants affected / at risk   20/164 (12.20%)   0/165 (0.00%) 
Injection site extravasation † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Injection site reaction † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Localised oedema † 1     
# participants affected / at risk   0/164 (0.00%)   3/165 (1.82%) 
Malaise † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Mucosal inflammation † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Oedema † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Oedema peripheral † 1     
# participants affected / at risk   6/164 (3.66%)   4/165 (2.42%) 
Pyrexia † 1     
# participants affected / at risk   96/164 (58.54%)   14/165 (8.48%) 
Soft tissue inflammation † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cholecystitis chronic † 1     
# participants affected / at risk   5/164 (3.05%)   2/165 (1.21%) 
Cholelithiasis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hepatic cyst † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hepatic steatosis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hepatitis chronic active † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hepatitis toxic † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Hepatomegaly † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hyperbilirubinaemia † 1     
# participants affected / at risk   4/164 (2.44%)   0/165 (0.00%) 
Liver disorder † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Immune system disorders     
Allergy to arthropod bite † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cytokine release syndrome † 1     
# participants affected / at risk   7/164 (4.27%)   0/165 (0.00%) 
Drug hypersensitivity † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypersensitivity † 1     
# participants affected / at risk   5/164 (3.05%)   1/165 (0.61%) 
Mycotic allergy † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Seasonal allergy † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Infections and infestations     
Acute sinusitis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Ascariasis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Bronchitis † 1     
# participants affected / at risk   15/164 (9.15%)   5/165 (3.03%) 
Bronchopneumonia † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Bullous impetigo † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Candidiasis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Conjunctivitis infective † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Cystitis † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Cytomegalovirus infection † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Folliculitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Herpes simplex † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Herpes zoster † 1     
# participants affected / at risk   4/164 (2.44%)   3/165 (1.82%) 
Infection † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Influenza † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Klebsiella bacteraemia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Laryngitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Nasopharyngitis † 1     
# participants affected / at risk   7/164 (4.27%)   8/165 (4.85%) 
Neutropenic infection † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Oral fungal infection † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Oral herpes † 1     
# participants affected / at risk   3/164 (1.83%)   3/165 (1.82%) 
Otitis media † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Perirectal abscess † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pharyngitis † 1     
# participants affected / at risk   6/164 (3.66%)   5/165 (3.03%) 
Pneumonia † 1     
# participants affected / at risk   6/164 (3.66%)   3/165 (1.82%) 
Pulpitis dental † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Respiratory tract infection † 1     
# participants affected / at risk   4/164 (2.44%)   5/165 (3.03%) 
Respiratory tract infection viral † 1     
# participants affected / at risk   4/164 (2.44%)   2/165 (1.21%) 
Rhinitis † 1     
# participants affected / at risk   3/164 (1.83%)   3/165 (1.82%) 
Sinusitis † 1     
# participants affected / at risk   1/164 (0.61%)   3/165 (1.82%) 
Skin candida † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Staphylococcal infection † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Tinea versicolour † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Tonsillitis † 1     
# participants affected / at risk   1/164 (0.61%)   3/165 (1.82%) 
Tooth infection † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Tracheitis † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   3/164 (1.83%)   3/165 (1.82%) 
Urinary tract infection † 1     
# participants affected / at risk   3/164 (1.83%)   1/165 (0.61%) 
Urinary tract infection pseudomonal † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Viral infection † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Viral upper respiratory tract infection † 1     
# participants affected / at risk   3/164 (1.83%)   1/165 (0.61%) 
Injury, poisoning and procedural complications     
Arthropod bite † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Injury † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Joint sprain † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   6/164 (3.66%)   5/165 (3.03%) 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   2/164 (1.22%)   2/165 (1.21%) 
Beta 2 microglobulin decreased † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Blood albumin decreased † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Blood alkaline phosphatase increased † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Blood bilirubin increased † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Blood creatinine increased † 1     
# participants affected / at risk   4/164 (2.44%)   3/165 (1.82%) 
Blood lactate dehydrogenase increased † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Body temperature increased † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Breath sounds abnormal † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Cd4 lymphocytes decreased † 1     
# participants affected / at risk   4/164 (2.44%)   2/165 (1.21%) 
Creatinine renal clearance decreased † 1     
# participants affected / at risk   5/164 (3.05%)   5/165 (3.03%) 
Cytomegalovirus test positive † 1     
# participants affected / at risk   19/164 (11.59%)   1/165 (0.61%) 
Gamma-glutamyltransferase increased † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Haemoglobin decreased † 1     
# participants affected / at risk   4/164 (2.44%)   5/165 (3.03%) 
Hepatic enzyme increased † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Lymphocyte count decreased † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Neutrophil count decreased † 1     
# participants affected / at risk   6/164 (3.66%)   7/165 (4.24%) 
Neutrophil pelger-huet anomaly present † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Platelet count decreased † 1     
# participants affected / at risk   6/164 (3.66%)   10/165 (6.06%) 
Urine uric acid increased † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Weight decreased † 1     
# participants affected / at risk   2/164 (1.22%)   2/165 (1.21%) 
Weight increased † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
White blood cell count decreased † 1     
# participants affected / at risk   7/164 (4.27%)   3/165 (1.82%) 
Metabolism and nutrition disorders     
Decreased appetite † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Dehydration † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Diabetes mellitus † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Fluid retention † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Gout † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hyperglycaemia † 1     
# participants affected / at risk   3/164 (1.83%)   2/165 (1.21%) 
Hyperkalaemia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hypernatraemia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hyperphosphataemia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hyperproteinaemia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hyperuricaemia † 1     
# participants affected / at risk   1/164 (0.61%)   4/165 (2.42%) 
Hypoalbuminaemia † 1     
# participants affected / at risk   4/164 (2.44%)   1/165 (0.61%) 
Hypokalaemia † 1     
# participants affected / at risk   4/164 (2.44%)   0/165 (0.00%) 
Hypophosphataemia † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Hypoproteinaemia † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Tumour lysis syndrome † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   3/164 (1.83%)   2/165 (1.21%) 
Arthritis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Arthritis reactive † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Back pain † 1     
# participants affected / at risk   4/164 (2.44%)   3/165 (1.82%) 
Bone pain † 1     
# participants affected / at risk   9/164 (5.49%)   0/165 (0.00%) 
Gouty arthritis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Groin pain † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Mastication disorder † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Musculoskeletal pain † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Myalgia † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Myositis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Osteoarthritis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Osteochondrosis † 1     
# participants affected / at risk   3/164 (1.83%)   2/165 (1.21%) 
Osteonecrosis of jaw † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pain in extremity † 1     
# participants affected / at risk   2/164 (1.22%)   2/165 (1.21%) 
Rheumatoid arthritis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Rotator cuff syndrome † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Scoliosis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Spinal deformity † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Spinal osteoarthritis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Benign lung neoplasm † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Gastrointestinal carcinoma † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Lipoma † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Malignant pleural effusion † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Metastases to liver † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Paraneoplastic pemphigus † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Paraproteinaemia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Seborrhoeic keratosis † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Skin papilloma † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Nervous system disorders     
Cognitive disorder † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Dizziness † 1     
# participants affected / at risk   4/164 (2.44%)   5/165 (3.03%) 
Dysaesthesia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Dysgeusia † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Facial neuralgia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Headache † 1     
# participants affected / at risk   14/164 (8.54%)   4/165 (2.42%) 
Hypoaesthesia † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Memory impairment † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Neuralgia † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Neuropathy peripheral † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Paraesthesia † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Peripheral sensory neuropathy † 1     
# participants affected / at risk   1/164 (0.61%)   3/165 (1.82%) 
Post herpetic neuralgia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Radicular pain † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Sciatica † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Somnolence † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Sphenopalatine neuralgia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Syncope † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Toxic encephalopathy † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Tremor † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Psychiatric disorders     
Agitation † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Anxiety † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Confusional state † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Depression † 1     
# participants affected / at risk   2/164 (1.22%)   1/165 (0.61%) 
Disorientation † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Hallucination † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Insomnia † 1     
# participants affected / at risk   5/164 (3.05%)   2/165 (1.21%) 
Sleep disorder † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Renal and urinary disorders     
Calculus urinary † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Chromaturia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Crystalluria † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Cystitis haemorrhagic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Dysuria † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Leukocyturia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Nephrolithiasis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Nephroptosis † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Pollakiuria † 1     
# participants affected / at risk   5/164 (3.05%)   3/165 (1.82%) 
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%) 
Renal impairment † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Urinary retention † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Calculus prostatic † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Metrorrhagia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Vaginal haemorrhage † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Bronchitis chronic † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Bronchospasm † 1     
# participants affected / at risk   8/164 (4.88%)   0/165 (0.00%) 
Cough † 1     
# participants affected / at risk   13/164 (7.93%)   8/165 (4.85%) 
Dysphonia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Dyspnoea † 1     
# participants affected / at risk   5/164 (3.05%)   1/165 (0.61%) 
Epistaxis † 1     
# participants affected / at risk   1/164 (0.61%)   2/165 (1.21%) 
Haemoptysis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hiccups † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Laryngeal polyp † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Lung infiltration † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Nasal dryness † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Obstructive airways disorder † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Oropharyngeal pain † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Pleural effusion † 1     
# participants affected / at risk   3/164 (1.83%)   0/165 (0.00%) 
Pleurisy † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pneumonitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Pulmonary congestion † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Respiratory alkalosis † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Respiratory disorder † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Respiratory failure † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Sinus congestion † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Throat irritation † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Wheezing † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Angioedema † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Dermatitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Dermatitis allergic † 1     
# participants affected / at risk   13/164 (7.93%)   4/165 (2.42%) 
Drug eruption † 1     
# participants affected / at risk   6/164 (3.66%)   0/165 (0.00%) 
Dry skin † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Eczema † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Erythema † 1     
# participants affected / at risk   1/164 (0.61%)   3/165 (1.82%) 
Exfoliative rash † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hyperhidrosis † 1     
# participants affected / at risk   3/164 (1.83%)   3/165 (1.82%) 
Hyperkeratosis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Night sweats † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Petechiae † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Pruritus † 1     
# participants affected / at risk   13/164 (7.93%)   4/165 (2.42%) 
Pruritus allergic † 1     
# participants affected / at risk   3/164 (1.83%)   1/165 (0.61%) 
Pruritus generalised † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Rash † 1     
# participants affected / at risk   25/164 (15.24%)   5/165 (3.03%) 
Rash erythematous † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Rash generalised † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Rash macular † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Rash maculo-papular † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Rash papular † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Seborrhoeic dermatitis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Skin exfoliation † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Skin hyperpigmentation † 1     
# participants affected / at risk   0/164 (0.00%)   2/165 (1.21%) 
Skin lesion † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Skin swelling † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Skin ulcer † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Swelling face † 1     
# participants affected / at risk   0/164 (0.00%)   1/165 (0.61%) 
Urticaria † 1     
# participants affected / at risk   22/164 (13.41%)   4/165 (2.42%) 
Urticaria vesiculosa † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Vascular disorders     
Arteriosclerosis obliterans † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Deep vein thrombosis † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Flushing † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hot flush † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypertension † 1     
# participants affected / at risk   11/164 (6.71%)   6/165 (3.64%) 
Hypertensive crisis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Hypotension † 1     
# participants affected / at risk   3/164 (1.83%)   2/165 (1.21%) 
Phlebitis † 1     
# participants affected / at risk   2/164 (1.22%)   0/165 (0.00%) 
Systolic hypertension † 1     
# participants affected / at risk   1/164 (0.61%)   1/165 (0.61%) 
Temporal arteritis † 1     
# participants affected / at risk   1/164 (0.61%)   0/165 (0.00%) 
Varicose vein † 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



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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
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