10
5 What Are the Risks of Treatment with Optune
®
?
In a clinical study of Optune together with temozolomide (before the tumor reappeared), the device led to skin irritation
in about half of the patients (53%). Most of these cases were not severe and were treated with topical creams. Only a
handful of patients (2%) had severe skin irritation.
The table below shows the occurrence of severe medical problems in patients using Optune together with
temozolomide compared to patients on temozolomide alone.
Medical Problem Optune with Temozolomide Temozolomide
Lower white and red blood cell counts 59 out of 456 subjects (13%) 23 out of 216 subjects (11%)
Vomiting, nausea and diarrhea 23 out of 456 subjects (5%) 8 out of 216 subjects (4%)
General disorders 42 out of 456 subjects (9%) 13 out of 216 subjects (6%)
Infections 32 out of 456 subjects (7%) 10 out of 216 subjects (5%)
Rash under device transducer arrays and
other injuries
24 out of 456 subjects (5%) 7 out of 216 subjects (3%)
Muscle disorders 21 out of 456 subjects (5%) 9 out of 216 subjects (4%)
Nutrition disorders 16 out of 456 subjects (4%) 10 out of 216 subjects (5%)
Brain disorders 109 out of 456 subjects (24%) 43 out of 216 subjects (20%)
Behavioral disorders 17 out of 456 subjects (4%) 6 out of 216 subjects (3%)
Breathing disorders 24 out of 456 subjects (5%) 11 out of 216 subjects (5%)
Bleeding and clotting disorders 19 out of 456 subjects (4%) 5 out of 216 subjects (2%)
Heart disorders 5 out of 456 subjects (1%) 3 out of 216 subjects (1%)
The table below shows the occurrence of certain events when Optune was used correctly and incorrectly together with
temozolomide in the clinical study in patients whose tumor has not yet reappeared.
Occurrence of Certain Problems with Correct and Incorrect Use of Optune Together with
Temozolomide
Event Likelihood of Event Outcome/Harm Likelihood of Outcome
Correct use
Skin reaction 235 out of 456 subjects
(52%)
Mild or moderate scalp redness
(rash with little sores or blisters)
235 out of 242 subjects
(97%)
Use in patients with implanted
shunts in the brain
4 out of 437 patients Shunt malfunction or infection 0 out of 4 subjects (0%)
Incorrect use
Skin reaction 7 out of 437 subjects (2%) Open sores on scalp leading
to treatment breaks and
hospitalization
7 out of 7 subjects
(100%)
Use in a patient with a
pacemaker
0 out of 437 subjects (0%) Heart problems Unknown
Use in pregnant women 0 out of 437 subjects (0%) Unknown Unknown
Use in patients with implanted
electronic devices or bullet
fragments
0 out of 437 subjects (0%) Unknown Unknown
Known allergic reaction to
electrode gels
0 out of 437 subjects (0%) Increased redness and itching,
(rarely may even lead to severe
allergic reactions such as shock
and breathing failure)
Unknown
Opening the device for service
by untrained personnel
0 out of 437 subjects (0%) Damage to the device and risk
of electric shock
Unknown
Incorrect uses not predicted Unknown Unknown Unknown
What Are the Risks of Treatment with Optune?
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