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1 Anamorelin for cachexia follow up CRF final 28.8.18 Staff email: Participant Id: Initials of person entering data: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP 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)

ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

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Page 1: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

1

Anamorelin for cachexia follow up CRF final 28.8.18

Staff email:

Participant Id:

Initials of person entering data:

ANAMORELIN FOR CACHEXIA

Series 20

FOLLOW UP 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)

Page 2: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

2

Anamorelin for cachexia follow up CRF final 28.8.18

T3-Third follow up visit post baseline/assessment

Date of visit/assessment

dd/mm/yyyy

T3: 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%; 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

Page 3: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

3

Anamorelin for cachexia follow up CRF final 28.8.18

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

Toxicity assessment

Diarrhoea □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

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

Hyperglycaemia/Hypoglycaemia (since last seen) □

⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia

⃝ Asymptomatic hyperglycaemia

Page 4: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

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Anamorelin for cachexia follow up CRF final 28.8.18

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 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

Page 5: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

5

Anamorelin for cachexia follow up CRF final 28.8.18

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

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

Page 6: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

6

Anamorelin for cachexia follow up CRF final 28.8.18

5. Was the adverse event confirmed by any objective evidence? ⃝ Yes (if 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 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

Page 7: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

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Anamorelin for cachexia follow up CRF final 28.8.18

T4- Fourth follow up visit post baseline/Assessment

Date of visit/assessment

dd/mm/yyyy

T4: 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)

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

Page 8: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

8

Anamorelin for cachexia follow up CRF final 28.8.18

Cachexia □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

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

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

Toxicity assessment

Diarrhoea □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

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

Page 9: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

9

Anamorelin for cachexia follow up CRF final 28.8.18

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

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)

Page 10: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

10

Anamorelin for cachexia follow up CRF final 28.8.18

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

Was there 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

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

Page 11: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

11

Anamorelin for cachexia follow up CRF final 28.8.18

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

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

Page 12: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

12

Anamorelin for cachexia follow up CRF final 28.8.18

T5- Fifth Follow up visit post baseline/Assessment

Date of visit/assessment

dd/mm/yyyy

T5: 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)

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

Page 13: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

13

Anamorelin for cachexia follow up CRF final 28.8.18

Cachexia □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

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

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

Toxicity assessment

Diarrhoea □

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

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

Page 14: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

14

Anamorelin for cachexia follow up CRF final 28.8.18

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

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)

Page 15: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

15

Anamorelin for cachexia follow up CRF final 28.8.18

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

Was there 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

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

Page 16: ANAMORELIN FOR CACHEXIA Series 20 FOLLOW UP CASE … for... · 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition;

16

Anamorelin for cachexia follow up CRF final 28.8.18

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

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