Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason
Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy
Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib.
NCT01735955_exc_T1
Negation
discontinued
NCT01735955_exc_T2
Multiplier
permanently
NCT01735955_exc_T3
Drug
nilotinib
NCT01735955_exc_T4
Procedure
treatment
NCT01735955_exc_T5
Condition
unacceptable toxicity
NCT01735955_exc_T6
Observation
non-compliance
NCT01735955_exc_T7
Procedure
study procedures
NCT01735955_exc_T8
Negation
withdrawal
NCT01735955_exc_T9
Observation
consent
NCT01735955_exc_T10
Observation
any other reason
NCT01735955_exc_T11
Scope
unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason
NCT01735955_exc_T12
Qualifier
Novartis sponsored
NCT01735955_exc_T13
Observation
participated in a combination trial
NCT01735955_exc_T15
Procedure
treatment
NCT01735955_exc_T16
Temporal
currently
NCT01735955_exc_T17
Drug
any medications
NCT01735955_exc_T18
Qualifier
have the potential to prolong the QT interval
NCT01735955_exc_T19
Qualifier
inducing Torsade de Pointes
NCT01735955_exc_T20
Scope
have the potential to prolong the QT interval or inducing Torsade de Pointes
NCT01735955_exc_T22
Observation
Pregnant
NCT01735955_exc_T23
Observation
nursing
NCT01735955_exc_T24
Person
women
NCT01735955_exc_T25
Observation
lactating
NCT01735955_exc_T26
Observation
hcG laboratory test
NCT01735955_exc_T27
Value
positive
NCT01735955_exc_T28
Person
Women
NCT01735955_exc_T29
Observation
child-bearing potential
NCT01735955_exc_T30
Observation
physiologically capable of becoming pregnant
NCT01735955_exc_T31
Person
women
NCT01735955_exc_T32
Negation
unless
NCT01735955_exc_T33
Qualifier
highly effective methods
NCT01735955_exc_T34
Observation
contraception
NCT01735955_exc_T35
Temporal
during the study
NCT01735955_exc_T36
Temporal
for 30 days after the final dose of nilotinib
NCT01735955_exc_T37
Reference_point
the final dose of nilotinib
NCT01735955_exc_T38
Scope
during the study and for 30 days after the final dose of nilotinib
NCT01735955_exc_T39
Scope
women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib
NCT01735955_exc_T40
Scope
Women of child-bearing potential