1
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)
2
Anamorelin for cachexia final CRF 4.7.18
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.
3
Anamorelin for cachexia final CRF 4.7.18
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
4
Anamorelin for cachexia final CRF 4.7.18
□ 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
5
Anamorelin for cachexia final CRF 4.7.18
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% or BMI 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
6
Anamorelin for cachexia final CRF 4.7.18
Commencement dose Anamorelin
Dose (mg) Per 24hrs
Toxicity assessment T0
Hyperglycaemia/Hypoglycaemia (since last seen) □
⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia
⃝ Asymptomatic hyperglycaemia
Diarrhoea □
⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable
NCI Criteria
1.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
⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable
Other:
Additional other □ – please specify below
⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable
Additional other:
7
Anamorelin for cachexia final CRF 4.7.18
Which toxicity/symptom is the most troublesome?
Select:
⃝ Anorexia
⃝ Cachexia
⃝ Diarrhoea
⃝ Hypoglycaemia/hyperglycaemia
⃝ Other
⃝ Additional other
Date of next planned visit:
dd/mm/yyyy
8
Anamorelin for cachexia final CRF 4.7.18
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 □
⃝ 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 ⃝ no symptom ⃝ ungradable
Fearon and Strasser et al 2011
1.Pre-cachexia-Weight loss /= 5% or BMI 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
9
Anamorelin for cachexia final CRF 4.7.18
Current weight (kgs)
Weight in kgs:
% Fat (if available)
% water ( if available)
% muscle (if available)
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
10
Anamorelin for cachexia final CRF 4.7.18
Toxicity assessment
Diarrhoea □
⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable
NCI Criteria
1.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
Hyperglycaemia/Hypoglycaemia (since last seen) □
⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia
⃝ Asymptomatic hyperglycaemia
Other □ – please specify below
⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable
Other:
Additional Other □ – please specify below
⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable
Additional other:
Which toxicity/symptom is the most troublesome?
Select:
⃝ Anorexia
⃝ Cachexia
⃝ Diarrhoea
⃝ Hypoglycaemia/hyperglycaemia
⃝ Other
⃝ Additional other
11
Anamorelin for cachexia final CRF 4.7.18
Symptomatic Benefit Assessment
Assessed / Not assessed reason
⃝ Assessed
