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1 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Participant ID
Initials of person entering data
Staff email
CONFIDENTIAL CASE REPORT FORM
Gabapentinoids-(Gabapentin/Pregabalin) – Paediatrics
Series 23
Palliative Care Clinical Studies Collaborative (PaCCSC) RAPID Pharmacovigilance in Palliative Care
The case report form (CRF) is to be completed in compliance with PaCCSC Standard Operating Procedures (SOP)
2 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
T0 - Baseline
Demographics Gender ⃝ Male ⃝ Female
Ethnicity
⃝ European
⃝ Maori
⃝ Pacific Peoples
⃝ Asian
⃝ Middle Eastern
⃝ Latin American
⃝ Aboriginal
⃝ African
⃝ Aboriginal
⃝ Torres Strait Islander
⃝ Other ethnicity: Please specify____________________________________
Age (0 to <18yrs)
□ Years_______ □ Months________
Weight (kg)
Primary life limiting illness ⃝ Advanced cancer
- □ Solid tumour
- □ Haematological malignancy
- □ CNS tumour
⃝ Neurological disease
- □ Neuromuscular disorders
- □ Static encephalopathy – GMFCS I-V
- □ Progressive encephalopathy or Neurodegenerative disease
⃝ Cardiac condition
⃝ Respiratory condition
⃝ End stage renal failure
⃝ Hepatic failure
⃝ Other –please specify________________
3 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Palliative Care Phase? Stable Unstable Deteriorating End of Life
Stable Phase: The person's symptoms are adequately controlled by established management. Further interventions to maintain symptom control and quality of life have been planned. Unstable: The person experiences the development of a new problem or a rapid increase in the severity of existing problems either of which requires an urgent change in management or emergency treatment. Deteriorating: The person experiences a gradual worsening of existing symptoms or the development of new but expected problems. These require the application of specific plans of care and regular review but not urgent or emergency treatment. End of Life Care Phase: Death is likely in a matter of days and no acute intervention is planned or required.
Karnofsky/Lansky Performance Status (please circle appropriate status) The Karnofsky Scale is designed for recipients aged 16 years and older, and the Lansky Scale is designed for patients less than 16 years old. Use the table below to determine the score (10-100) that best represents the patient’s activity status.
Karnofsky/Lansky Scale Karnofsky Scale (patient’s age >/= 16yrs) Lansky Scale (recipients age < 16yrs)
Able to carry on normal activity; no special care is needed
Able to carry on normal activity; no special care is needed
100 Normal, no complaints, no evidence of disease
100 Fully active
90 Able to carry on normal activity 90 Minor restriction in physically strenuous play 80 Normal activity with effort 80 Restricted in strenuous play, tires more
easily, otherwise active
Unable to work, able to live at home cares for most personal needs, a varying amount of
assistance needed
Mild to moderate restriction
70 Cares for self, unable to carry on normal activity or to do active work
70 Both greater restrictions of and less time spent in active play
60 Requires occasional assistance but is able to care for most needs
60 Ambulatory up to 50% of the time, limited active play with assistance/supervision
50 Requires considerable assistance and frequent medical care
50 Considerable assistance required for any active play, fully able to engage in quiet play
Unable to care for self, requires equivalent of institutional or hospital care, disease may be
progressing rapidly
Moderate to severe restriction
40 Disabled, requires special care and assistance
40 Able to initiate quiet activities
30 Severely disabled, hospitalisation indicated, although death not imminent
30 Needs considerable assistance for quiet activity
20 Very sick, hospitalisation necessary 20 Limited to very passive activity initiated by others (e.g. TV)
10 Moribund, fatal process progressing rapidly 10 Completely disabled, not even passive play
Karnofsky/Lansky Scale Score
4 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Baseline – T0-Medication Commencement Date of assessment
dd/mm/yyyy
Medication of Interest ⃝ Gabapentin
⃝ Pregabalin
Date of Medication Commencement
dd/mm/yyyy
Commencement dose (mg/kg/dose)
Frequency of Dose (daily, BD, TDS, QID)
Indications of Interest (tick only one) ⃝ Neuropathic pain (Pain caused by damage or disease affecting the somatosensory nervous system.
Neuropathic pain may be associated with abnormal sensations called dysesthesia or pain from normally non-painful stimuli (allodynia). It may have continuous and/or episodic (paroxysmal) components).
⃝ Nociplastic pain (Pain that arises from altered nociception despite no clear evidence of actual or
threatened tissue damage causing the activation of peripheral nociceptors or evidence for disease or lesion of the somatosensory system causing the pain) E.g. neuro-irritability, visceral hyperalgesia and central neural sensitisation syndrome
5 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Symptom Severity Score – (Revised FLACC Scale)
Revised FLACC Scale SCORING
Categories 0 1 2
Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested, sad, appears worried
Frequent to constant quivering chin, clenched jaw, distressed looking face, expression of fright/panic
Legs Normal position or relaxed, usual tone and motion to limbs
Uneasy, restless, tense, occasional tremors
Kicking, or legs drawn up, marked increase in spasticity, constant tremors, jerking
Activity Lying quietly, normal position moves easily, regular, rhythmic respirations
Squirming, shifting back and forth, tense, tense. guarded movements, mildly agitated, shallow respirations, intermittent sighs
Arched. Rigid or jerking, severe agitation, head banging, shivering, breath holding, gasping, severe splinting
Cry No cry (awake or asleep)
Moans or whimpers: occasional complaint, occasional verbal outbursts, constant grunting
Crying steadily, screams, sobs, frequent complaints, repeated outbursts, constant grunting
Consolability Content, relaxed Reassured by occasional touching, hugging, or being talked to: distractible
Difficult to console or comfort, pushing caregiver away, resisting care or comfort measures
Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. Total Revised FLACC Score
OR Faces Pain Scale – Revised (FPS-R) – see appendix for instructions on use
Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so “0” = “no pain” and “10” = “very much pain”. Record score below. ⃝ 0 ⃝ 2 ⃝ 4 ⃝ 6 ⃝ 8 ⃝ 10
6 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Concurrent Medications (classes of drugs) (tick all that apply)
□ Benzodiazepines
□ Opioids ( include Tramadol)
□ Anti-emetics
□ Laxatives/aperients
□ Tricyclic antidepressants
□ NMDA antagonists – Ketamine, Dextromethorphan
□ Alpha 2 agonists - Clonidine
□ Paracetamol/NSAIDS
□ Baclofen
□ Anti-reflux medications
□ Anti-epileptics
□ Antipsychotics
□ Steroids
□ Other – please specify
□ Other – please specify
Baseline Symptom/Toxicity Assessment
Fatigue □
1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest
2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
7 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
NCI Criteria 1. Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL
3. Obtundation or stupor
4. Life-threatening consequences; urgent intervention indicated
5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated
3.Severe cognitive disability; significant impairment of work/school/life performance
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
Tremor □ 1 2 3 ungradable no symptom
NCI Criteria 1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □ 1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □ 1 2 3 ungradable no symptom
NCI Criteria
1. Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss.
3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
8 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Vomiting □ 1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated
5. Death
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
Other symptom/toxicity (if applicable) □ Please specify here
Mild Moderate Severe Ungradable
Additional ‘Other’ symptom/ toxicity (if applicable) □ Please specify here
Mild Moderate Severe Ungradable
9 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Which symptom/toxicity is the most troublesome for the child? ⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional Other symptom/toxicity
⃝ Not applicable
10 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
T1 – 14 days post Baseline T1: Assessed/Not assessed reason ⃝ Assessed today (continue)
⃝ Died
⃝ Not able to be contacted / located
⃝ Too unwell
⃝ Other
Date of Death
dd/mm/yyyy
End Survey here Date of Assessment
dd/mm/yyyy
Please provide reason why if today’s date of assessment is not 14 days after Baselines date of assessment.
Total dose given in the last 24 hours (mg) How long has the patient been on this dose (days) Was there any benefit?
□ Complete resolution □ Partial resolution □ No change □ Worse
Medication changes
Medication of interest dose maintained/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased New medication(s) added
Please specify new medication(s) here
Please specify new dose of medication of interest here
11 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Symptom Severity Score – (Revised FLACC Scale)
Revised FLACC Scale SCORING
Categories 0 1 2
Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested, sad, appears worried
Frequent to constant quivering chin, clenched jaw, distressed looking face, expression of fright/panic
Legs Normal position or relaxed, usual tone and motion to limbs
Uneasy, restless, tense, occasional tremors
Kicking, or legs drawn up, marked increase in spasticity, constant tremors, jerking
Activity Lying quietly, normal position moves easily, regular, rhythmic respirations
Squirming, shifting back and forth, tense, tense. guarded movements, mildly agitated, shallow respirations, intermittent sighs
Arched. Rigid or jerking, severe agitation, head banging, shivering, breath holding, gasping, severe splinting
Cry No cry (awake or asleep)
Moans or whimpers: occasional complaint, occasional verbal outbursts, constant grunting
Crying steadily, screams, sobs, frequent complaints, repeated outbursts, constant grunting
Consolability Content, relaxed Reassured by occasional touching, hugging, or being talked to: distractible
Difficult to console or comfort, pushing caregiver away, resisting care or comfort measures
Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. Total Revised FLACC Score
OR Faces Pain Scale – Revised (FPS-R) - see appendix for instructions on use
Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so “0” = “no pain” and “10” = “very much pain”. Record score below.
12 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
⃝ 0 ⃝ 2 ⃝ 4 ⃝ 6 ⃝ 8 ⃝ 10
Toxicity/symptom assessment (T1) Please select all symptoms that were present at assessment.
Fatigue □ 1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL
3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1.Mild but more than usual drowsiness or sleepiness 2. Moderate sedation; limiting instrumental ADL
3. Obtundation or stupor 4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
Tremor □
1 2 3 ungradable no symptom
13 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
NCI Criteria 1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1. Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss.
3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
14 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Other symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child?
⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional ‘Other’ symptom/toxicity
⃝ Not applicable
15 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Key questions derived from the Naranjo modified check list (only complete this if a toxicity scored 3 or more)
1. Did the adverse reaction appear after the suspected drug was given? ⃝ Yes
⃝ No
⃝ Don’t know
2. Did the adverse reaction improve when the drug was discontinued or a specific
antagonist was given? ⃝ Yes
⃝ No
⃝ Don’t know
3. Are there alternative causes (other than the drug) that could on their own have caused
the reaction? ⃝ Yes
⃝ No
⃝ Don’t know
4. Did the patient have a similar reaction to the same or similar drug in any previous
exposure? ⃝ Yes
⃝ No
⃝ Don’t know
5. Was the adverse event confirmed by any objective evidence?
⃝ Yes
⃝ No
⃝ Don’t know
Toxicity assessment follow-up
What is the intended treatment based on the assessment today?
No change to medication of interest/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased
Has a medication been added to treat a specific toxicity?
Yes
No
16 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Please specify medication to treat toxicity
T2 – 28 days post Baseline T2: Assessed/Not assessed reason ⃝ Assessed today (continue)
⃝ Died
⃝ Not able to be contacted / located
⃝ Too unwell
⃝ Other
Date of Death
dd/mm/yyyy
End Survey here Date of Assessment
dd/mm/yyyy
Please provide reason why if today’s date of assessment is not 28 days after Baselines date of assessment.
Total dose given in the last 24 hours (mg) How long has the patient been on this dose (days) Was there any benefit?
□ complete resolution □ partial resolution □ no change □ worse
Medication changes
Medication of interest dose maintained/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased New medication(s) added
Please specify new medication(s) here
Please specify new dose of medication of interest here
17 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Symptom Severity Score – (Revised FLACC Scale)
Revised FLACC Scale SCORING
Categories 0 1 2
Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested, sad, appears worried
Frequent to constant quivering chin, clenched jaw, distressed looking face, expression of fright/panic
Legs Normal position or relaxed, usual tone and motion to limbs
Uneasy, restless, tense, occasional tremors
Kicking, or legs drawn up, marked increase in spasticity, constant tremors, jerking
Activity Lying quietly, normal position moves easily, regular, rhythmic respirations
Squirming, shifting back and forth, tense, tense. guarded movements, mildly agitated, shallow respirations, intermittent sighs
Arched. Rigid or jerking, severe agitation, head banging, shivering, breath holding, gasping, severe splinting
Cry No cry (awake or asleep)
Moans or whimpers: occasional complaint, occasional verbal outbursts, constant grunting
Crying steadily, screams, sobs, frequent complaints, repeated outbursts, constant grunting
Consolability Content, relaxed Reassured by occasional touching, hugging, or being talked to: distractible
Difficult to console or comfort, pushing caregiver away, resisting care or comfort measures
Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. Total Revised FLACC Score
OR Faces Pain Scale – Revised (FPS-R) - see appendix for instructions on use Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so “0” = “no pain” and “10” = “very much pain”. Record score below. ⃝ 0 ⃝ 2 ⃝ 4 ⃝ 6 ⃝ 8 ⃝ 10
18 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Symptom/Toxicity assessment (T2) Please select all symptoms that were present at assessment.
Fatigue □
1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1.Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor 4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
19 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Tremor □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1. Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization
20 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/ Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
Other symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child? ⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional ‘Other’ symptom/toxicity
⃝ Not applicable
21 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Key questions derived from the Naranjo modified check list (only complete this if a toxicity scored 3 or more) 1. Did the adverse reaction appear after the suspected drug was given?
⃝ Yes
⃝ No
⃝ Don’t know
2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?
⃝ Yes
⃝ No
⃝ Don’t know
3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? ⃝ Yes
⃝ No
⃝ Don’t know
4. Did the patient have a similar reaction to the same or similar drug in any previous
exposure? ⃝ Yes
⃝ No
⃝ Don’t know
5. Was the adverse event confirmed by any objective evidence?
⃝ Yes
⃝ No
⃝ Don’t know
Toxicity assessment follow-up
What is the intended treatment based on the assessment today?
No change to medication of interest/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased
Has a medication been added to treat a specific toxicity?
Yes
No Please specify medication to treat toxicity
22 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
T3 – 6 weeks post Baseline T3: Assessed/Not assessed reason ⃝ Assessed today (continue)
⃝ Died
⃝ Not able to be contacted / located
⃝ Too unwell
⃝ Other
Date of Death
dd/mm/yyyy
End Survey here Date of Assessment
dd/mm/yyyy
Please provide reason why if today’s date of assessment is not 6 weeks after Baselines date of assessment.
Total dose given in the last 24 hours (mg) How long has the patient been on this dose (days) Was there any benefit?
□ complete resolution □ partial resolution □ no change □ worse
Medication changes
Medication of interest dose maintained/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased New medication(s) added
Please specify new medication(s) here
Please specify new dose of medication of interest here
23 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Symptom Severity Score – (Revised FLACC Scale)
Revised FLACC Scale SCORING
Categories 0 1 2
Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested, sad, appears worried
Frequent to constant quivering chin, clenched jaw, distressed looking face, expression of fright/panic
Legs Normal position or relaxed, usual tone and motion to limbs
Uneasy, restless, tense, occasional tremors
Kicking, or legs drawn up, marked increase in spasticity, constant tremors, jerking
Activity Lying quietly, normal position moves easily, regular, rhythmic respirations
Squirming, shifting back and forth, tense, tense. guarded movements, mildly agitated, shallow respirations, intermittent sighs
Arched. Rigid or jerking, severe agitation, head banging, shivering, breath holding, gasping, severe splinting
Cry No cry (awake or asleep)
Moans or whimpers: occasional complaint, occasional verbal outbursts, constant grunting
Crying steadily, screams, sobs, frequent complaints, repeated outbursts, constant grunting
Consolability Content, relaxed Reassured by occasional touching, hugging, or being talked to: distractible
Difficult to console or comfort, pushing caregiver away, resisting care or comfort measures
Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. Total Revised FLACC Score
OR
Faces Pain Scale – Revised (FPS-R) - see appendix for instructions on use Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so “0” = “no pain” and “10” = “very much pain”. Record score below.
24 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
⃝ 0 ⃝ 2 ⃝ 4 ⃝ 6 ⃝ 8 ⃝ 10
Toxicity/symptom assessment (T3) Please select all symptoms that were present at assessment.
Fatigue □
1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor 4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
25 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Tremor □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1 .Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent
26 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
Other symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child? ⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional Other symptom/toxicity
⃝ Not applicable
27 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Key questions derived from the Naranjo modified check list (only complete if a toxicity scored 3 or more) 1. Did the adverse reaction appear after the suspected drug was given?
⃝ Yes
⃝ No
⃝ Don’t know
2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?
⃝ Yes
⃝ No
⃝ Don’t know
3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? ⃝ Yes
⃝ No
⃝ Don’t know
4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? ⃝ Yes
⃝ No
⃝ Don’t know
5. Was the adverse event confirmed by any objective evidence?
⃝ Yes
⃝ No
⃝ Don’t know
Toxicity assessment follow-up
What is the intended treatment based on the assessment today?
No change to medication of interest/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased
Has a medication been added to treat a specific toxicity?
Yes
No
28 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Please specify medication to treat toxicity
T4 – 12 weeks post Baseline T4: Assessed/Not assessed reason ⃝ Assessed today (continue)
⃝ Died
⃝ Not able to be contacted / located
⃝ Too unwell
⃝ Other
Date of Death
dd/mm/yyyy
End Survey here Date of Assessment
dd/mm/yyyy
Please provide reason why if today’s date of assessment is not 12 weeks after Baselines date of assessment.
Total dose given in the last 24 hours (mg) How long has the patient been on this dose (days) Was there any benefit?
□ complete resolution □ partial resolution □ no change □ worse
Medication changes
Medication of interest dose maintained/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased New medication(s) added
Please specify new medication(s) here
Please specify new dose of medication of interest here
29 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Symptom Severity Score – (Revised FLACC Scale)
Revised FLACC Scale SCORING
Categories 0 1 2
Face No particular expression or smile
Occasional grimace or frown, withdrawn, disinterested, sad, appears worried
Frequent to constant quivering chin, clenched jaw, distressed looking face, expression of fright/panic
Legs Normal position or relaxed, usual tone and motion to limbs
Uneasy, restless, tense, occasional tremors
Kicking, or legs drawn up, marked increase in spasticity, constant tremors, jerking
Activity Lying quietly, normal position moves easily, regular, rhythmic respirations
Squirming, shifting back and forth, tense, tense. guarded movements, mildly agitated, shallow respirations, intermittent sighs
Arched. Rigid or jerking, severe agitation, head banging, shivering, breath holding, gasping, severe splinting
Cry No cry (awake or asleep)
Moans or whimpers: occasional complaint, occasional verbal outbursts, constant grunting
Crying steadily, screams, sobs, frequent complaints, repeated outbursts, constant grunting
Consolability Content, relaxed Reassured by occasional touching, hugging, or being talked to: distractible
Difficult to console or comfort, pushing caregiver away, resisting care or comfort measures
Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. Total Revised FLACC Score
OR
Faces Pain Scale – Revised (FPS-R) - see appendix for instructions on use Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so “0” = “no pain” and “10” = “very much pain”. Record score below.
30 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
⃝ 0 ⃝ 2 ⃝ 4 ⃝ 6 ⃝ 8 ⃝ 10
Toxicity/symptom assessment (T4) Please select all symptoms that were present at assessment.
Fatigue □ 1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor 4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
Ataxia □ 1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
Tremor □
1 2 3 ungradable no symptom
NCI Criteria
31 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1 .Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Occasional/minimal production of sputum with cough 2. Moderate sputum production; limiting instrumental ADL 3. Persistent or copious production of sputum; limiting self-care ADL
Other symptom/toxicity (if applicable) □ Please specify here
32 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child? ⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional Other symptom/toxicity
⃝ Not applicable
33 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Key questions derived from the Naranjo modified check list (only complete if a toxicity scored 3 or more) 1. Did the adverse reaction appear after the suspected drug was given?
⃝ Yes
⃝ No
⃝ Don’t know
2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?
⃝ Yes
⃝ No
⃝ Don’t know
3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? ⃝ Yes
⃝ No
⃝ Don’t know
4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? ⃝ Yes
⃝ No
⃝ Don’t know
5. Was the adverse event confirmed by any objective evidence?
⃝ Yes
⃝ No
⃝ Don’t know
Toxicity assessment follow-up
What is the intended treatment based on the assessment today?
No change to medication of interest/continue current dose Medication of interest dose decreased Medication of interest dose increased Medication of interest ceased
Has a medication been added to treat a specific toxicity?
Yes
No
34 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Please specify medication to treat toxicity
Medication Cessation (complete this page at any time the medication of
interest is ceased) Date of assessment
dd/mm/yyyy
Medication was ceased (related to indication of interest) ⃝ Symptom resolved
⃝ Symptom continued unchanged
⃝ Symptom worsened
⃝ Symptom resolved - date of resolution ___dd/mm/yyyy__
⃝ Symptom worsened - Grade (NCI)
Medication was ceased (related to other reasons) ⃝Toxicity
⃝ Patient unable to take medication
⃝ Other
Please specify the other reason medication was ceased
Please specify the patient’s inability to take medication
35 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Adhoc A- Unscheduled Adverse Event/Toxicity Assessment
Please complete the survey below.
Were there any adhoc toxicities? Yes No
Date of assessment
dd/mm/yyyy
Fatigue □
1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor
4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
36 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
Tremor □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1 .Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
37 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
Other symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child? ⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional ‘Other’ symptom/toxicity
⃝ Not applicable
38 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Adhoc B - Unscheduled Adverse Event/Toxicity Assessment
Please complete the survey below.
Were there any adhoc toxicities? Yes No
Date of assessment
dd/mm/yyyy
Fatigue □
1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor 4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
39 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
Tremor □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild symptoms
2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms 2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1 .Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
40 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Suicidal Ideation □
1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
Other symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child?
⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other symptom/toxicity
⃝ Additional Other symptom/toxicity
⃝ Not applicable
41 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Adhoc C -
Please complete the survey below.
Were there any adhoc toxicities? Yes No
Date of assessment
dd/mm/yyyy
Fatigue □
1 2 3 ungradable no symptom
NCI Criteria: 1.Fatigue relieved by rest 2.Fatigue not relieved by rest; limiting instrumental ADL 3.Fatigue not relieved by rest, limiting self-care ADL
Dizziness □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild unsteadiness or sensation of movement 2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL 3. Severe unsteadiness or sensation of movement
Somnolence □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. Mild but more than usual drowsiness or sleepiness
2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor 4. Life-threatening consequences; urgent intervention indicated 5. Death
Cognitive/behavioural Disturbance □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational
services/devices not indicated 2.Moderate cognitive disability; interfering with work/school/life performance but capable of independent
living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance
Ataxia □
1 2 3 ungradable no symptom
NCI Criteria 1. Asymptomatic; clinical or diagnostic observations only; intervention not indicated 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL; mechanical assistance indicated
42 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Tremor □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL
Nystagmus □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild symptoms
2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL
Headache □
1 2 3 ungradable no symptom
NCI Criteria 1.Mild pain 2.Moderate pain; limiting instrumental ADL 3.Severe pain; limiting self-care ADL
Nausea □
1 2 3 ungradable no symptom
NCI Criteria 1 .Loss of appetite without alteration in eating habits
2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.
Vomiting □
1 2 3 4 5 ungradable no symptom
NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5. Death
Suicidal Ideation □ 1 2 3 ⃝ 4 ungradable no symptom
NCI Criteria 1.Increased thoughts of death but no wish to kill oneself 2.Suicidal ideation with no specific plan or intent 3.Specific plan to commit suicide without serious intent to die which may not require hospitalization 4.Specific plan to commit suicide with serious intent to die which requires hospitalization
43 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19
Oropharyngeal/Respiratory Secretions □
1 2 3 ungradable no symptom
NCI Criteria 1. Mild 2. Moderate 3. Severe
Other symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here
mild moderate severe ungradable
Which symptom/toxicity is the most troublesome for the child?
⃝ Fatigue
⃝ Dizziness
⃝ Somnolence
⃝ Ataxia
⃝ Cognitive/behavioural disturbance
⃝ Tremors
⃝ Nystagmus
⃝ Headache
⃝ Nausea
⃝ Vomiting
⃝ Suicidal Ideation ⃝ Secretions
⃝ Other toxicity
⃝ Additional ‘Other’ toxicity
⃝ Not applicable