Clinical trial NCT03954106
Conditions: DLBCL Neurotoxicity Syndromes
Keywords: CAR-T
Sponsor: Jazz Pharmaceuticals
Start date: 2019-10-04; Completion date: 2020-09-30
Enrollment: 25 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
This is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta.

Detailed description:

Arms: arm 1: Part 1 (lead-in phase) will evaluate a 2.5 mg/kg/dose regimen before escalating to a 6.25 mg/kg/dose regimen.

After the Safety Assessment Committee establishes the recommended phase 2 dose based on dose-limiting toxicities during Part 1, Part 2 will enroll subjects at the recommended phase 2 dose.
Interventions: intervention 1: Defibrotide
Intervention descriptions: intervention 1: * Part 1: Defibrotide 2.5 mg/kg/dose or 6.25 mg/kg/dose once daily as a single dose on CAR-T Day -5, -4, and -3 before lymphodepletion, then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).
* Part 2 Recommended Phase 2 Dose: Defibrotide 6.25 mg/kg/dose once daily as a single dose on CAR-T Day -5, -4, and -3 before lymphodepletion, then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).

Protocol documents:
Prot_000.pdf: 
PI
PI


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CONFIDENTIAL
Page 3 of 65


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CONFIDENTIAL
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Page 48 of 65


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CONFIDENTIAL
Page 49 of 65


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Nervous system disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Abducens nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the abducens nerve (sixth cranial nerve). 
Accessory nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the accessory nerve (eleventh cranial nerve). 
Acoustic nerve disorder NOS 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the acoustic nerve (eighth cranial nerve). 
Akathisia 
Mild restlessness or increased 
motor activity 
Moderate restlessness or 
increased motor activity; 
limiting instrumental ADL 
Severe restlessness or 
increased motor activity; 
limiting self care ADL 
- 
- 
Definition: A disorder characterized by an uncomfortable feeling of inner restlessness and inability to stay still; this is a side effect of some psychotropic drugs. 
Amnesia 
Mild; transient memory loss 
Moderate; short term memory 
loss; limiting instrumental ADL 
Severe; long term memory 
loss; limiting self care ADL 
- 
- 
Definition: A disorder characterized by systematic and extensive loss of memory. 
Anosmia 
Present 
- 
- 
- 
- 
Definition: A disorder characterized by a change in the sense of smell. 
Aphonia 
- 
- 
Voicelessness; unable to 
speak 
- 
- 
Definition: A disorder characterized by the inability to speak. It may result from injuries to the vocal cords or may be functional (psychogenic). 
Arachnoiditis 
Mild symptoms 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by inflammation of the arachnoid membrane and adjacent subarachnoid space. 
Ataxia 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL; mechanical assistance 
indicated 
- 
- 
Definition: A disorder characterized by lack of coordination of muscle movements resulting in the impairment or inability to perform voluntary activities. 
Brachial plexopathy 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by regional paresthesia of the brachial plexus, marked discomfort and muscle weakness, and limited movement in the arm or hand. 
Central nervous system 
necrosis 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate 
symptoms; 
corticosteroids indicated 
Severe symptoms; medical 
intervention indicated 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by a necrotic process occurring in the brain and/or spinal cord. 
Cerebrospinal fluid leakage 
Post-craniotomy: 
asymptomatic; 
Post-lumbar 
puncture: transient headache; 
postural care indicated 
Post-craniotomy: 
moderate 
symptoms; 
medical 
intervention indicated; Post- 
lumbar puncture: persistent 
moderate symptoms; blood 
patch indicated 
Severe symptoms; medical 
intervention indicated 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by loss of cerebrospinal fluid into the surrounding tissues. 
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CONFIDENTIAL
Page 50 of 65


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Nervous system disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Cognitive disturbance 
Mild cognitive disability; not 
interfering 
with 
work/school/life performance; 
specialized 
educational 
services/devices not indicated 
Moderate cognitive disability; 
interfering 
with 
work/school/life performance 
but capable of independent 
living; specialized resources on 
part time basis indicated
Severe 
cognitive 
disability; 
significant 
impairment 
of 
work/school/life performance 
- 
- 
Definition: A disorder characterized by a conspicuous change in cognitive function. 
Concentration impairment 
Mild inattention or decreased 
level of concentration 
Moderate 
impairment 
in 
attention or decreased level of 
concentration; 
limiting 
instrumental ADL 
Severe impairment in attention 
or 
decreased 
level 
of 
concentration; limiting self care 
ADL 
- 
- 
Definition: A disorder characterized by a deterioration in the ability to concentrate. 
Depressed level of 
consciousness 
Decreased level of alertness 
Sedation; slow response to 
stimuli; limiting instrumental 
ADL 
Difficult to arouse 
Life-threatening 
consequences; 
coma; 
urgent 
ntervention 
indicated 
Death 
Definition: A disorder characterized by a decrease in ability to perceive and respond. 
Dizziness 
Mild 
unsteadiness 
or 
sensation of movement 
Moderate unsteadiness or 
sensation of movement; 
limiting instrumental ADL 
Severe unsteadiness or 
sensation of movement; 
limiting self care ADL 
- 
- 
Definition: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking. 
Dysarthria 
Mild slurred speech 
Moderate 
impairment 
of 
articulation or slurred speech 
Severe 
impairment 
of 
articulation or slurred speech 
- 
- 
Definition: A disorder characterized by slow and slurred speech resulting from an inability to coordinate the muscles used in speech. 
Dysesthesia 
Mild sensory alteration 
Moderate sensory alteration; 
limiting instrumental ADL 
Severe sensory alteration; 
limiting self care ADL 
- 
- 
Definition: A disorder characterized by distortion of sensory perception, resulting in an abnormal and unpleasant sensation. 
Dysgeusia 
Altered taste but no change in 
diet 
Altered taste with change in 
diet (eg, oral supplements); 
noxious or unpleasant taste; 
loss of taste 
- 
- 
- 
Definition: A disorder characterized by abnormal sensual experience with the taste of foodstuffs; it can be related to a decrease in the sense of smell. 
Dysphasia 
Awareness 
of 
receptive 
or 
expressive characteristics; not 
impairing 
ability 
to 
communicate 
Moderate 
receptive 
or 
expressive 
characteristics; 
impairing 
ability 
to 
communicate spontaneously 
Severe receptive or expressive 
characteristics; 
impairing 
ability 
to 
read, 
write 
or 
communicate intelligibly 
- 
- 
Definition: A disorder characterized by impairment of verbal communication skills, often resulting from brain damage. 
Edema cerebral 
- 
- 
- 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by swelling due to an excessive accumulation of fluid in the brain. 
Encephalopathy 
Mild symptoms 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by a pathologic process involving the brain. 
Extrapyramidal disorder 
Mild involuntary movements 
Moderate involuntary 
movements; limiting 
instrumental ADL 
Severe 
involuntary 
movements or torticollis; 
limiting self care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by abnormal, repetitive, involuntary muscle movements, frenzied speech and extreme restlessness. 
Facial muscle weakness 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by a reduction in the strength of the facial muscles. 
Facial nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the facial nerve (seventh cranial nerve). 
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CONFIDENTIAL
Page 51 of 65


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Nervous system disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Glossopharyngeal 
nerve 
disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by dysfunction of the glossopharyngeal nerve (ninth cranial nerve). 
Guillain-Barre syndrome 
Mild symptoms 
Moderate 
symptoms; 
limiting 
instrumental 
ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; 
urgen 
intervention indicated; 
intubation 
Death 
Definition: A disorder characterized by the body’s immune system attacking the peripheral nervous system causing ascending paralysis. 
Headache 
Mild pain 
Moderate pain; limiting 
instrumental ADL 
Severe pain; limiting self care 
ADL 
- 
- 
Definition: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve. 
Hydrocephalus 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate 
symptoms; 
intervention not indicated 
Severe symptoms or 
neurological 
deficit; 
intervention indicated 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain. 
Hypersomnia 
Mild increased need for sleep 
Moderate increased need for 
sleep 
Severe increased need for 
sleep 
- 
- 
Definition: A disorder characterized by excessive sleepiness during the daytime. 
Hypoglossal nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the hypoglossal nerve (twelfth cranial nerve). 
Intracranial hemorrhage 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; medical 
intervention indicated 
Ventriculostomy, 
ICP 
monitoring, intraventricular 
thrombolysis, or operative 
intervention indicated 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by bleeding from the cranium. 
Ischemia cerebrovascular 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms 
- 
- 
- 
Definition: A disorder characterized by a decrease or absence of blood supply to the brain caused by obstruction (thrombosis or embolism) of an artery resulting in neurological 
damage. 
Lethargy 
Mild symptoms; reduced 
alertness and awareness 
Moderate symptoms; limiting 
instrumental ADL 
- 
- 
- 
Definition: A disorder characterized by a decrease in consciousness characterized by mental and physical inertness. 
Leukoencephalopathy 
Asymptomatic; 
small 
focal 
T2/FLAIR 
hyperintensities; 
involving periventricular white 
matter or <1/3 of susceptible 
areas of cerebrum +/- mild 
increase in subarachnoid space 
(SAS) 
and/or 
mild 
ventriculomegaly 
Moderate 
symptoms; 
focal 
T2/FLAIR 
hyperintensities, 
involving periventricular white 
matter extending into centrum 
semiovale or involving 1/3 to 
2/3 of susceptible areas of 
cerebrum 
+/- 
moderate 
increase 
in 
SAS 
and/or 
moderate ventriculomegaly 
Severe 
symptoms; 
extensive 
T2/FLAIR 
hyperintensities, 
involving periventricular white 
matter involving 2/3 or more of 
susceptible areas of cerebrum 
+/- moderate to severe 
increase in SAS and/or 
moderate 
to 
severe 
ventriculomegaly
Life-threatening consequences; 
extensive 
T2/FLAIR 
hyperintensities, 
involving 
periventricular 
white 
matter 
involving most of susceptible 
areas of cerebrum 
+/- moderate to severe 
increase in SAS and/or 
moderate
to
severe
Death 
Definition: A disorder characterized by diffuse reactive astrocytosis with multiple areas of necrotic foci without inflammation. 
Memory impairment 
Mild memory impairment 
Moderate memory 
impairment; limiting 
instrumental ADL 
Severe memory impairment; 
limiting self care ADL 
- 
- 
Definition: A disorder characterized by a deterioration in memory function. 
Meningismus 
Mild symptoms 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by neck stiffness, headache, and photophobia resulting from irritation of the cerebral meninges. 
Movements involuntary 
Mild symptoms 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
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CONFIDENTIAL
Page 52 of 65


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Nervous system disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Definition: A disorder characterized by uncontrolled and purposeless movements. 
Muscle weakness left-sided 
Symptomatic; perceived by 
patient but not evidence 
on physical exam 
Symptomatic; evidence 
on 
physical 
exam; 
limiting 
instrumental 
Limiting self care ADL 
- 
- 
Definition: A disorder characterized by a reduction in the strength of the muscles on the left side of the body. 
Muscle weakness right-sided 
Symptomatic; perceived by 
patient but not evidence 
on physical exam 
Symptomatic; evidence 
on 
physical 
exam; 
limiting 
instrumental 
Limiting self care ADL 
- 
- 
Definition: A disorder characterized by a reduction in the strength of the muscles on the right side of the body. 
Myasthenia gravis 
Asymptomatic 
or 
mild 
symptoms; 
clinical 
or 
diagnostic 
observations 
only; 
intervention 
not 
indicated 
Moderate; 
minimal, 
local 
or 
noninvasive 
intervention indicated; 
limiting age-appropriate 
instrumental ADL 
Severe or medically significant 
but 
not 
immediately 
life-threatening; 
hospitalization or prolongation 
of 
existing 
hospitalization 
indicated; limiting self care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by weakness and rapid fatigue of any of the skeletal muscles. 
Neuralgia 
Mild pain 
Moderate pain; limiting 
instrumental ADL 
Severe pain; limiting self care 
ADL 
- 
- 
Definition: A disorder characterized by intense painful sensation along a nerve or group of nerves. 
Nystagmus 
- 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by involuntary movements of the eyeballs. 
Oculomotor nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the oculomotor nerve (third cranial nerve). 
Olfactory nerve disorder 
- 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the olfactory nerve (first cranial nerve). 
Paresthesia 
Mild symptoms 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by functional disturbances of sensory neurons resulting in abnormal cutaneous sensations of tingling, numbness, pressure, cold, and/or warmth. 
Peripheral motor neuropathy 
Asymptomatic; 
clinical 
or 
diagnostic observations only 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by damage or dysfunctionof the peripheral motor nerves. 
Peripheral sensory 
neuropathy 
Asymptomatic 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
- 
Definition: A disorder characterized by damage or dysfunction of the peripheral sensory nerves. 
Phantom pain 
Mild pain 
Moderate pain; limiting 
instrumental ADL 
Severe pain; limiting self care 
ADL 
- 
- 
Definition: A disorder characterized by a sensation of marked discomfort related to a limb or an organ that is removed from or is not physically part of the body. 
Presyncope 
- 
Present (eg, near fainting) 
- 
- 
- 
Definition: A disorder characterized by an episode of lightheadedness and dizziness which may precede an episode of syncope. 
Pyramidal tract syndrome 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by dysfunction of the corticospinal (pyramidal) tracts of the spinal cord. Symptoms include  an increase in the muscle tone in the lower extremities, 
hyperreflexia, positive Babinski and a decrease in fine motor coordination. 
Radiculitis 
Mild symptoms 
Moderate symptoms; medical 
intervention indicated; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by inflammation involving a nerve root. Patients experience marked discomfort radiating along a nerve path because of spinal pressure on the connecting 
nerve root. 
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CONFIDENTIAL
Page 53 of 65


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Nervous system disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Recurrent laryngeal nerve 
palsy 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms 
Severe symptoms; medical 
intervention 
indicated 
(eg, thyroplasty, vocal cord 
injection) 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by paralysis of the recurrent laryngeal nerve. 
Reversible 
posterior 
leukoencephalopathy 
syndrome 
- 
Moderate 
symptoms; 
limiting instrumental ADL 
Severe symptoms; limiting 
self 
care 
ADL; 
hospitalization 
Life-threatening 
consequences 
Death 
Definition: A disorder characterized by headaches, mental status changes, visual disturbances, and/or seizures associated with imaging findings of posterior leukoencephalopathy. It 
has been observed in association with hypertensive encephalopathy, eclampsia, and immunosuppressive and cytotoxic drug treatment. It is an acute or subacute reversible condition. 
Also known as posterior reversible encephalopathy syndrome (PRES). 
Seizure 
Brief partial seizure and no loss 
of consciousness 
Brief generalized seizure 
New 
onset 
seizures 
(partial or generalized); 
multiple seizures despite 
medical intervention 
Life-threatening 
consequences; 
prolonged 
repetitive seizures 
Death 
Definition: A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin. 
Somnolence 
Mild but more than usual 
drowsiness or sleepiness 
Moderate sedation; limiting 
instrumental ADL 
Obtundation or stupor 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by excessive sleepiness and drowsiness. 
Spasticity 
Mild or slight increase in 
muscle tone 
Moderate increase in muscle 
tone and increase in resistance 
through range of motion 
Severe increase in muscle 
tone 
and 
increase 
in 
resistance through range of 
motion 
Life-threatening consequences; 
unable to move active or 
passive range of motion 
Death 
Definition: A disorder characterized by increased involuntary muscle tone that affects the regions interfering with voluntary movement. It results in gait, movement, and speech 
disturbances. 
Spinal cord compression 
- 
- 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by pressure on the spinal cord. 
Stroke 
Incidental 
radiographic 
findings only 
Mild 
to 
moderate 
neurologic deficit; limiting 
instrumental ADL 
Severe neurologic deficit; 
limiting self care ADL; 
hospitalization 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by a decrease or absence of blood supply to the brain caused by obstruction (thrombosis or embolism) of an artery resulting in neurological damage. 
Syncope 
- 
- 
Fainting; orthostatic collapse 
- 
- 
Definition: A disorder characterized by spontaneous loss of consciousness caused by insufficient blood supply to the brain. 
Tendon reflux decreased 
Ankle reflex reduced 
Ankle reflex absent; other 
reflexes reduced 
Absence of all reflexes 
- 
- 
Definition: A disorder characterized by less than normal deep tendon reflexes. 
Transient ischemic attacks 
Mild neurologic deficit with or 
without imaging confirmation 
Moderate neurologic deficit 
with or without imaging 
confirmation 
- 
- 
- 
Definition: A disorder characterized by a brief attack (less than 24 hours) of cerebral dysfunction of vascular origin, with no persistent neurological deficit. 
Tremor 
Mild symptoms 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by the uncontrolled shaking movement of the whole body or individual parts. 
Trigeminal nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the trigeminal nerve (fifth cranial nerve). 
Trochlear nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by dysfunction of the trochlear nerve (fourth cranial nerve). 
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CONFIDENTIAL
Page 54 of 65


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Nervous system disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Vagus nerve disorder 
Asymptomatic; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by dysfunction of the vagus nerve (tenth cranial nerve). 
Vasovagal reaction 
- 
- 
Present 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
Definition: A disorder characterized by a sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It results from an increase in 
the stimulation of the vagus nerve. 
Nervous system disorders - 
Other, specify 
Asymptomatic 
or 
mild 
symptoms; 
clinical 
or 
diagnostic observations only; 
intervention not indicated 
Moderate; minimal, local or 
noninvasive 
intervention 
indicated; 
limiting 
age-appropriate instrumental 
ADL 
Severe or medically significant 
but 
not 
immediately 
life-threatening; hospitalization 
or 
prolongation 
of 
existing 
hospitalization 
indicated; 
disabling;  limiting self care ADL 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
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Psychiatric disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Agitation 
Mild mood alteration 
Moderate mood alteration 
Severe 
agitation; 
hospitalization not indicated 
Life-threatening 
consequences; 
urgent 
intervention indicated 
- 
Definition: A disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension. 
Anorgasmia 
Inability to achieve orgasm not 
adversely affecting relationship 
Inability to achieve orgasm 
adversely 
affecting 
relationship 
- 
- 
- 
Definition: A disorder characterized by an inability to achieve orgasm. 
Anxiety 
Mild symptoms; intervention 
not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care 
ADL; 
hospitalization 
indicated 
Life-threatening 
consequences; 
urgent 
intervention indicated 
- 
Definition: A disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable 
stimulus. 
Confusion 
Mild disorientation 
Moderate disorientation; 
limiting instrumental ADL 
Severe disorientation; limiting 
self care ADL 
Life-threatening 
consequences; 
urgent 
intervention indicated 
- 
Definition: A disorder characterized by a lack of clear and orderly thought and behavior. 
Delayed orgasm 
Delay in achieving orgasm not 
adversely affecting relationship 
Delay in achieving orgasm 
adversely 
affecting 
relationship 
- 
- 
- 
Definition: A disorder characterized by sexual dysfunction characterized by a delay in climax. 
Delirium 
Mild acute confusional state 
Moderate 
and 
acute 
confusional state; limiting 
instrumental ADL 
Severe and acute confusional 
state; limiting self care ADL; 
urgent intervention indicated; 
new onset 
Life-threatening 
consequences, 
threats of 
harm to self or others; 
urgent 
intervention 
indicated 
Death 
Definition: A disorder characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Usually, it is a reversible 
condition. 
Delusions 
- 
Moderate delusional 
symptoms 
Severe delusional symptoms; 
hospitalization not indicated; 
new onset 
Life-threatening 
consequences, 
threats of 
harm to self or others; 
hospitalization indicated 
Death 
Definition: A disorder characterized by false personal beliefs held contrary to reality, despite contradictory evidence and common sense. 
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Page 55 of 65


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Psychiatric disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Depression 
Mild depressive symptoms 
Moderate depressive 
symptoms; 
limiting 
instrumental ADL 
Severe depressive symptoms; 
limiting 
self 
care 
ADL; 
hospitalization not indicated 
Life-threatening 
consequences, 
threats of 
harm to self or others; 
hospitalization indicated 
Death 
Definition: A disorder characterized by melancholic feelings of grief or unhappiness. 
Euphoria 
Mild mood elevation 
Moderate mood elevation 
Severe mood elevation (eg, 
hypomania) 
- 
- 
Definition: A disorder characterized by an exaggerated feeling of well-being which is disproportionate to events and stimuli. 
Hallucinations 
Mild hallucinations (eg, 
perceptual distortions) 
Moderate hallucinations 
Severe 
hallucinations; 
hospitalization not indicated 
Life-threatening 
consequences, 
threats of 
harm to self or others; 
hospitalization indicated 
Death 
Definition: A disorder characterized by a false sensory perception in the absence of an external stimulus. 
Insomnia 
Mild difficulty falling asleep, 
staying asleep or waking up 
early 
Moderate difficulty falling 
asleep, staying asleep or 
waking up early 
Severe difficulty in falling 
asleep, staying asleep or 
waking up early 
- 
- 
Definition: A disorder characterized by difficulty in falling asleep and/or remaining asleep. 
Irritability 
Mild/ easily consolable 
Moderate; 
limiting 
instrumental ADL; increased 
attention indicated 
Severe abnormal or excessive 
response; limiting self care 
ADL; inconsolable; medical or 
psychiatric 
intervention 
indicated 
- 
- 
Definition: A disorder characterized by an abnormal responsiveness to stimuli or physiological arousal; may be in response to pain, fright, a drug, an emotional situation or a medical condition. 
Libido decreased 
Decrease in sexual interest 
not 
adversely 
affecting 
relationship 
Decrease in sexual interest 
adversely 
affecting 
relationship 
- 
- 
- 
Definition: A disorder characterized by a decrease in sexual desire. 
Libido increased 
Present 
- 
- 
- 
- 
Definition: A disorder characterized by an increase in sexual desire. 
Mania 
Mild manic symptoms (eg, 
elevated 
mood, 
rapid 
thoughts, 
rapid 
speech, 
decreased need for sleep) 
Moderate manic symptoms 
(eg, relationship and work 
difficulties; poor hygiene) 
Severe 
manic 
symptoms 
(eg, hypomania; major sexual or 
financial 
indiscretions); 
hospitalization 
not 
indicated; 
new onset
Life-threatening 
consequences, 
threats of 
harm to self or others; 
hospitalization indicated 
Death 
Definition: A disorder characterized by excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganization of behavior and elevation of mood. 
Personality change 
Mild personality change 
Moderate personality change 
Severe personality change; 
hospitalization not indicated 
Life-threatening 
consequences, 
threats of 
harm to self or others; 
hospitalization indicated 
- 
Definition: A disorder characterized by a conspicuous change in a person's behavior and thinking. 
Psychosis 
Mild psychotic symptoms 
Moderate psychotic symptoms 
(eg, 
disorganized 
speech; 
impaired reality testing) 
Severe psychotic symptoms 
(eg, 
paranoid; 
extreme 
disorganization); 
hospitalization not indicated; 
new onset 
Life-threatening 
consequences, 
threats of 
harm to self or others; 
hospitalization indicated 
Death 
Definition: A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor. 
Restlessness 
Mild symptoms; intervention 
not indicated 
Moderate symptoms; limiting 
instrumental ADL 
Severe symptoms; limiting self 
care ADL 
- 
- 
Definition: A disorder characterized by an inability to rest, relax or be still. 
Suicidal ideation 
Increased thoughts of death 
but no wish to kill oneself 
Suicidal ideation with no 
specific plan or intent 
Specific plan to commit suicide 
without serious intent to die 
which 
may 
not 
require 
hospitalization 
Specific plan to commit suicide 
with serious intent to die 
which requires hospitalization 
- 
Definition: A disorder characterized by thoughts of taking one's own life. 
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CONFIDENTIAL
Page 56 of 65


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Psychiatric disorders 
 
Grade 
CTCAE Term 
1 
2 
3 
4 
5 
Suicide attempt 
- 
- 
Suicide attempt or gesture 
without intent to die 
Suicide attempt with intent to 
die 
which 
requires 
hospitalization 
Death 
Definition: A disorder characterized by self-inflicted harm in an attempt to end one's own life. 
Psychiatric disorders - Other, 
specify 
Asymptomatic 
or 
mild 
symptoms; clinical or diagnostic 
observations only; intervention 
not indicated 
Moderate; minimal, local or 
noninvasive 
intervention 
indicated; 
limiting 
age- 
appropriate instrumental ADL 
Severe or medically significant 
but 
not 
immediately 
life- 
threatening; disabling;  limiting 
self care ADL 
Life-threatening consequences; 
hospitalization 
or 
urgent 
intervention indicated 
Death 
Abbreviations: ADL = activities of daily living; CTCAE = Common Terminology Criteria for Adverse Events. 
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