ANAMORELIN FOR CACHEXIA. Series 20 CASE REPORT FORM

Transcription

1 1 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 2 Staff Participant Id: Date of Baseline: dd/mm/yyyy Demographics Gender Male Female Age years Weight (kg) Height (cm) Primary Cancer Lung Bowel Liver Prostate Head and Neck Gastric Oesophageal Breast Pancreatic 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 3 Laboratory tests (Only if available) Serum albumin C-Reactive protein (CRP) Blood sugar level Haemoglobin A1C Creatinine Clearance Result Not available 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 4 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 5 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 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 ungradable no symptom ungradable Fearon and Strasser et al 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

6 6 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:

7 7 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 8 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) t able to be contacted/located Too unwell Other Date of Death (dd/mm/yyyy) Anorexia 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 no symptom ungradable Fearon and Strasser et al 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

9 9 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 10 Toxicity assessment 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 Hyperglycaemia/Hypoglycaemia (since last seen) Symptomatic hypoglycaemia Symptomatic hyperglycaemia Asymptomatic hyperglycaemia Other please specify below Other: Additional Other please specify below Additional other: Which toxicity/symptom is the most troublesome? Select: Anorexia Cachexia Diarrhoea Hypoglycaemia/hyperglycaemia Other Additional other

11 11 Symptomatic Benefit Assessment Assessed / Not assessed reason Assessed today (continue) t assessed (go to either date of next planned contact OR completion of data collection form) t 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? 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) Please specify new medication here

12 12 Key questions derived from the Naranjo modified check list 1. Did the adverse reaction appear after the suspected drug was given? 2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? 5. Was the adverse event confirmed by any objective evidence? (if yes please specify below)

13 13 Post toxicity assessment What is the intended treatment based on today s assessment? 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? N/A Date of planned next visit/assessment dd/mm/yyyy

14 14 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) t 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 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

15 15 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 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 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

16 16 Hyperglycaemia/Hypoglycaemia (since last seen) Symptomatic hypoglycaemia Symptomatic hyperglycaemia Asymptomatic hyperglycaemia Other please specify below Other : Additional other please specify below 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) t assessed (go to either date of next planned contact OR completion of data collection form) t able to be contacted / located Too unwell Other Total dose Anamorelin given in last 24 hours (mgs)

17 17 How long has the patient been on this dose (days) Was there any benefit? 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) Key questions derived from the Naranjo modified check list 1. Did the adverse reaction appear after the suspected drug was given? 2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?

18 18 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? 5. Was the adverse event confirmed by any objective evidence? (please specify below) Post toxicity assessment What is the intended treatment based on today s assessment? 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 N/A Date of planned next visit/assessment dd/mm/yyyy

19 19 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

20 20 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) 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 (please specify below) Please specify new medication here: Anorexia 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

21 21 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 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 Hyperglycaemia/Hypoglycaemia (since last seen) Symptomatic hypoglycaemia Symptomatic hyperglycaemia Asymptomatic hyperglycaemia Other please specify below Other: Additional other please specify below Additional other:

22 22 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? 2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? 5. Was the adverse event confirmed by any objective evidence? Please specify objective evidence of adverse event:

23 23 Post toxicity assessment What is the intended treatment based on today s assessment? 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 N/A

24 24 Unscheduled Adverse Event Assessment (b) 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) 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 (please specify below) Please specify new medication here: Anorexia 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

25 25 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 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 Hyperglycaemia/Hypoglycaemia (since last seen) Symptomatic hypoglycaemia hyperglycaemia Symptomatic hyperglycaemia Asymptomatic Other please specify below Other: Additional other please specify below Additional other:

26 26 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? 2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? 5. Was the adverse event confirmed by any objective evidence? Please specify objective evidence of adverse event:

27 27 Post toxicity assessment What is the intended treatment based on today s assessment? 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 N/A

28 28 Unscheduled Adverse Event Assessment (c) 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) 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 (please specify below) Please specify new medication here: Anorexia 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

29 29 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 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 Hyperglycaemia/Hypoglycaemia (since last seen) Symptomatic hypoglycaemia Symptomatic hyperglycaemia Asymptomatic hyperglycaemia Other please specify below Other: Additional other please specify below Additional other:

30 30 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? 2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? 5. Was the adverse event confirmed by any objective evidence? Please specify objective evidence of adverse event:

31 31 Post toxicity assessment What is the intended treatment based on today s assessment? 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 N/A