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Anamorelin for cachexia final CRF 4.7.18

ANAMORELIN FOR CACHEXIA

Series 20

CASE REPORT FORM

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)

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Staff email:

Participant Id:

Date of Baseline: dd/mm/yyyy

Demographics

Gender Male □ Female □

Age ____ years

Weight (kg)___

Height (cm)___

Primary Cancer

Lung □ Gastric □

Bowel □ Oesophageal □

Liver □ Breast □

Prostate □ Pancreatic □

Head and Neck □ Other (please specify) □

Palliative Care Phase

⃝ Stable ⃝ Unstable ⃝ Deteriorating ⃝ Terminal

Stable: The person's symptoms are adequately controlled by established management. Further interventions to maintain symptom control and quality of life have been planned. Unstable Phase: 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 Phase: 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. Terminal Care Phase: Death is likely in a matter of days and no acute intervention is planned or required.

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Laboratory tests (Only if

available)

Result Not available

Serum albumin C-Reactive protein (CRP) Blood sugar level Haemoglobin A1C Creatinine Clearance

Charlson Comorbidity Index

□ Myocardial infarction

□ Congestive cardiac failure

□ Peripheral vascular disease

□ Cerebrovascular disease

□ Dementia

□ Chronic pulmonary disease

□ Connective tissue disease

□ Ulcer disease

□ Mild liver disease

□ Hemiplegia

□ Moderate or severe renal disease

□ Diabetes with end organ damage

□ Moderate or severe liver disease

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□ AIDS

□ Diabetes

If diabetic please indicate if:

□ Type I □ Type II

□ Insulin dependent □ Oral hypoglycaemic agents □ Controlled by diet alone

How often is BSL monitoring being done?

□ At least daily □ Less than daily □ No regular monitoring of BSLs.

Australian Modified Karnofsky Performance Scale (AKPS)

100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity; minor signs of symptoms 80 Normal activity with effort; some signs of symptoms or disease 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most of his needs 50 Requires considerable assistance and frequent medical care 40 In bed more than 50% of the time 30 Almost completely bedfast 20 Totally bedfast and requiring extensive nursing care by professionals and/or family 10 Comatose or barely rousable 0 Dead Not able to determine

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T0 Baseline Medication Commencement

Time:

Estimated weight loss in the past three months: (kgs; patient’s recall)

Current weight (kgs)

Weight in kgs:

% Fat (if available)

% water ( if available)

% muscle (if available)

Anorexia □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

NCI Criteria 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated 3.Associated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); tube feeding or TPN indicated 4.Life-threatening consequences; urgent intervention indicated 5.Death

Cachexia □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ ungradable ⃝ no symptom ⃝ ungradable

Fearon and Strasser et al 2011 1.Pre-cachexia-Weight loss </= 5%; Anorexia and metabolic change 2. Cachexia-weight loss >/= 5% or BMI <20% kg/M2 and weight loss > 2%; Often reduced food intake/systemic inflammation 3. Refractory cachexia – variable degree of cachexia; Cancer disease both procatabolic and not responsive to anticancer treatment; Low performance score (ECOG/WHO score 3 or 4; less than 3 months survival expected

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Commencement dose Anamorelin

Dose (mg) Per 24hrs

Toxicity assessment T0

Hyperglycaemia/Hypoglycaemia (since last seen) □

⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia

⃝ Asymptomatic hyperglycaemia

Diarrhoea □


NCI Criteria 1.Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline 2.Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline 3.Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4.Life-threatening consequences; urgent intervention indicated 5.Death

Other □ – please specify below


Other:

Additional other □ – please specify below


Additional other:

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Which toxicity/symptom is the most troublesome? Select:

⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other

Date of next planned visit:

dd/mm/yyyy

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T1-Second visit/assessment

Date of visit/assessment

dd/mm/yyyy

T1: Assessed/Not assessed reason

⃝ Assessed today (continue)

⃝ Died (if died please record below)

⃝ Not able to be contacted/located

⃝ Too unwell

⃝ Other

Date of Death (dd/mm/yyyy)

Anorexia □



Cachexia □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ no symptom ⃝ ungradable

Fearon and Strasser et al 2011 1.Pre-cachexia-Weight loss </= 5%; Anorexia and metabolic change 2. Cachexia-weight loss >/= 5% or BMI <20% kg/M2 and weight loss > 2%; Often reduced food intake/systemic inflammation 3. Refractory cachexia – variable degree of cachexia; Cancer disease both procatabolic and not responsive to anticancer treatment; Low performance score (ECOG/WHO score 3 or 4; less than 3 months survival expected

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Weight in kgs:






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Toxicity assessment

Diarrhoea □








Other:

Additional Other □ – please specify below


Additional other:

Which toxicity/symptom is the most troublesome? Select:

⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other

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Symptomatic Benefit Assessment Assessed / Not assessed reason ⃝ Assessed today (continue) ⃝ Not assessed (go to either date of next planned contact OR completion of data collection form) ⃝ Not able to be contacted / located ⃝ Too unwell ⃝ Other Total dose Anamorelin given in last 24 hours (mgs)

How long has the patient been on this dose (days)

Did the patient perceive any benefit?

⃝ Yes ⃝ No

Medication Changes (pick one of the 4)

⃝ Anamorelin dose maintained/continue current dose ⃝ Anamorelin dose increased (please specify below) ⃝ Anamorelin dose decreased (please specify below) ⃝ Anamorelin dose ceased

If Anamorelin dose increased or decreased above, please specify new dose (mgs)

Was a new medication added for side effects? (If yes please specify below) ⃝ Yes ⃝ No Please specify new medication here

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Key questions derived from the Naranjo modified check list 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 (if yes please specify below) ⃝ No ⃝ Don’t know

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Post toxicity assessment What is the intended treatment based on today’s assessment?

⃝ No change to Anamorelin continue current dose ⃝ Anamorelin ceased ⃝ Anamorelin reduced ⃝ Anamorelin increased – please specify dose

Has a medication been added to treat a specific toxicity? Yes ⃝ No ⃝ If yes please specify medication.

Based on the assessment today has the toxicity resolved?

⃝ Yes ⃝ No ⃝ N/A

Date of planned next visit/assessment dd/mm/yyyy

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T2- Assessment/ third visit

Date of visit/assessment

dd/mm/yyyy

T2: Assessed/Not assessed reason

⃝ Assessed today (continue)

⃝ Died (if died please record below)

⃝ Not able to be contacted/located

⃝ Too unwell

⃝ Other

Date of Death (dd/mm/yyyy)


Weight in kgs:




Anorexia □



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Cachexia □


Fearon and Strasser et al Criteria 1.Pre-cachexia-Weight loss </= 5%; Anorexia and metabolic change 2. Cachexia-weight loss >/= 5% or BMI <20% kg/M2 and weight loss > 2%; Often reduced food intake/systemic inflammation 3. Refractory cachexia – variable degree of cachexia; Cancer disease both procatabolic and not responsive to anticancer treatment; Low performance score (ECOG/WHO score 3 or 4; less than 3 months survival expected



Toxicity assessment

Diarrhoea □



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Other :



Additional other:

Which toxicity/symptom is the most troublesome? Select: ⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other Symptomatic Benefit Assessment Assessed/Not assessed reason ⃝ Assessed today (continue) ⃝ Not assessed (go to either date of next planned contact OR completion of data collection form)

⃝ Not able to be contacted / located ⃝ Too unwell ⃝ Other Total dose Anamorelin given in last 24 hours (mgs)

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How long has the patient been on this dose (days)

Was there any benefit?

⃝ Yes ⃝ No

Medication Changes (pick one of the 4)



Was a new medication added for side effects- (if yes please specify below) ⃝ Yes ⃝ No

Key questions derived from the Naranjo modified check list 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

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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 (please specify below) ⃝ No ⃝ Don’t know Post toxicity assessment What is the intended treatment based on today’s assessment? ⃝ No change to Anamorelin/continue current dose ⃝ Anamorelin ceased ⃝ Anamorelin dose reduced ⃝ Anamorelin dose increased – please specify dose



Yes ⃝ No ⃝ N/A ⃝

Date of planned next visit/assessment dd/mm/yyyy

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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 ____________________________________________

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Unscheduled Adverse Event Assessment (a) Please complete the survey below. Were there any ad hoc toxicities?

Yes No Date of assessment

dd/mm/yyyy Was there any benefit?

Yes No What is the intended treatment based on the assessment today? Medication Changes (pick one of the 4)



Was a new medication added for side effects (please specify below) ⃝ Yes ⃝ No Please specify new medication here:

Anorexia □



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Cachexia □



Diarrhoea □








Other:



Additional other:

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Which toxicity/symptom is the most troublesome? Select: ⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other Key questions derived from the Naranjo modified check list 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 Please specify objective evidence of adverse event:

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Post toxicity assessment What is the intended treatment based on today’s assessment? ⃝ No change to Anamorelin/continue current dose ⃝ Anamorelin ceased ⃝ Anamorelin dose reduced ⃝ Anamorelin dose increased – please specify dose




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Unscheduled Adverse Event Assessment (b) Please complete the survey below. Were there any ad hoc toxicities?







Anorexia □



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Cachexia □



Diarrhoea □




⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia ⃝ Asymptomatic

hyperglycaemia



Other:



Additional other:

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Which toxicity/symptom is the most troublesome? Select: ⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other

Key questions derived from the Naranjo modified check list 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 Please specify objective evidence of adverse event:

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Unscheduled Adverse Event Assessment (c) Please complete the survey below. Were there any ad hoc toxicities?







Anorexia □



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Cachexia □



Diarrhoea □








Other:



Additional other:

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Which toxicity/symptom is the most troublesome? Select: ⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional Other Key questions derived from the Naranjo modified check list 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 Please specify objective evidence of adverse event:

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