palliative care clinical studies collaborative …...laxatives/aperients tricyclic antidepressants...

1 Paediatric Gabapentinoids V1.0 Final CRF 7.6.19

Participant ID

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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)


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________________


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


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


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


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 □


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 □


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 □


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 □


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


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




Categories 0 1 2
















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

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 □



Somnolence □


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



NCI Criteria 1.Mild cognitive disability; not interfering with work/school/life performance; specialized educational


living; specialized resources on part time basis indicated 3.Severe cognitive disability; significant impairment of work/school/life performance

Ataxia □



Tremor □




Nystagmus □



Headache □



Nausea □


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 □


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









mild moderate severe ungradable

Additional ‘Other’ symptom/toxicity (if applicable) □ Please specify here


Which symptom/toxicity is the most troublesome for the child?

⃝ Fatigue

⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting



⃝ Additional ‘Other’ symptom/toxicity

⃝ Not applicable


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

T2 – 28 days post Baseline T2: Assessed/Not assessed reason ⃝ Assessed today (continue)

⃝ Died


⃝ Too unwell

⃝ Other

Date of Death

dd/mm/yyyy


dd/mm/yyyy

Please provide reason why if today’s date of assessment is not 28 days after Baselines date of assessment.


□ complete resolution □ partial resolution □ no change □ worse

Medication changes







Categories 0 1 2
















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


Symptom/Toxicity assessment (T2) Please select all symptoms that were present at assessment.

Fatigue □


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 □



Somnolence □


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






Ataxia □




Tremor □



Nystagmus □



Headache □



Nausea □


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 □





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 □








⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting




⃝ Not applicable


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


⃝ Yes

⃝ No

⃝ Don’t know





Yes

No Please specify medication to treat toxicity


T3 – 6 weeks post Baseline T3: Assessed/Not assessed reason ⃝ Assessed today (continue)

⃝ Died


⃝ Too unwell

⃝ Other

Date of Death

dd/mm/yyyy


dd/mm/yyyy

Please provide reason why if today’s date of assessment is not 6 weeks after Baselines date of assessment.



Medication changes







Categories 0 1 2
















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


Fatigue □



Dizziness □



Somnolence □









Ataxia □




Tremor □



Nystagmus □



Headache □



Nausea □


NCI Criteria 1 .Loss of appetite without alteration in eating habits


Vomiting □





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









⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting




⃝ Not applicable


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


⃝ Yes

⃝ No

⃝ Don’t know


⃝ 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


⃝ Yes

⃝ No

⃝ Don’t know





Yes

No



T4 – 12 weeks post Baseline T4: Assessed/Not assessed reason ⃝ Assessed today (continue)

⃝ Died


⃝ Too unwell

⃝ Other

Date of Death

dd/mm/yyyy


dd/mm/yyyy

Please provide reason why if today’s date of assessment is not 12 weeks after Baselines date of assessment.



Medication changes







Categories 0 1 2
















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


Fatigue □ 1 2 3 ungradable no symptom


Dizziness □



Somnolence □









Ataxia □ 1 2 3 ungradable no symptom


Tremor □


NCI Criteria


1.Mild symptoms 2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL

Nystagmus □



Headache □



Nausea □




Vomiting □








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







⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting




⃝ Not applicable


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


⃝ Yes

⃝ No

⃝ Don’t know


⃝ 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


⃝ Yes

⃝ No

⃝ Don’t know





Yes

No



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


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 □



Dizziness □



Somnolence □



2. Moderate sedation; limiting instrumental ADL 3. Obtundation or stupor

4. Life-threatening consequences; urgent intervention indicated 5. Death







Ataxia □



Tremor □



Nystagmus □



Headache □



Nausea □




Vomiting □















⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting




⃝ Not applicable


Adhoc B - Unscheduled Adverse Event/Toxicity Assessment



Date of assessment

dd/mm/yyyy

Fatigue □



Dizziness □



Somnolence □










Ataxia □



Tremor □


NCI Criteria 1.Mild symptoms

2.Moderate symptoms; limiting instrumental ADL 3.Severe symptoms; limiting self-care ADL

Nystagmus □



Headache □



Nausea □




Vomiting □















⃝ Fatigue

⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting




⃝ Not applicable


Adhoc C -



Date of assessment

dd/mm/yyyy

Fatigue □



Dizziness □



Somnolence □









Ataxia □




Tremor □



Nystagmus □


NCI Criteria 1. Mild symptoms

2. Moderate symptoms; limiting instrumental ADL 3. Severe symptoms; limiting self-care ADL

Headache □



Nausea □




Vomiting □



Suicidal Ideation □ 1 2 3 ⃝ 4 ungradable no symptom











⃝ Fatigue

⃝ Dizziness

⃝ Somnolence

⃝ Ataxia


⃝ Tremors

⃝ Nystagmus

⃝ Headache

⃝ Nausea

⃝ Vomiting


⃝ Other toxicity

⃝ Additional ‘Other’ toxicity

⃝ Not applicable

palliative care clinical studies collaborative …...laxatives/aperients tricyclic antidepressants...

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