Palliative Care
Clinical Studies Collaborative
RAPID Pharmacovigilance
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Site………………………………………… Site code: _ _/ 04/_ _ _
Medication
DEXAMETHASONE
Indication
Anorexia
Time points
Baseline
Commenced
Toxicity
7 days after baseline
Clinical benefit
7 days after baseline
Ad hoc toxicity
ALSO any other toxicity observed
should be recorded in the
unscheduled toxicity pages up
until 4 weeks after baseline
Hyperglycaemia
1 - Fasting glucose value >ULN - 160 mg/dL; Fasting glucose value >ULN - 8.9 mmol/L
2 - Fasting glucose value >160 - 250 mg/dL; Fasting glucose value >8.9 - 13.9 mmol/L
3 - >250 - 500 mg/dL; >13.9 - 27.8; hospitalization indicated
4 - >500 mg/dL; >27.8 mmol/L; life- mmol/L; threatening consequences
5 - Death
Mania
1 - Mild manic symptoms (e.g., elevated mood, rapid thoughts, rapid speech, decreased
need for sleep)
2 - Moderate manic symptoms (e.g., relationship and work difficulties; poor hygiene)
3 - Severe manic symptoms (e.g., hypomania; major sexual or financial indiscretions);
hospitalization not indicated
4 - Life-threatening consequences, threats of harm to self or others; hospitalization
indicated
5 - Death
Toxicities - Dexamethasone
Euphoria
1 - Mild mood elevation
2 - Moderate mood elevation
3 - Severe mood elevation (e.g., hypomania)
Depression
1 - Mild depressive symptoms
2 - Moderate depressive symptoms; limiting instrumental ADL
3 - Severe depressive symptoms; limiting self care ADL; hospitalization not indicated
4 - Life-threatening consequences, threats of harm to self or others; hospitalization
indicated
5 - Death
Insomnia
1 - Mild difficulty falling asleep, staying asleep or waking up early
2 - Moderate difficulty falling asleep, staying asleep or waking up early
3 - Severe difficulty falling asleep, staying asleep or waking up early
Delirium
1 - Mild acute confusional state
2 - Moderate and acute confusional state; limiting instrumental ADL
3 - Severe and acute confusional state; limiting self care ADL; hospitalization indicated
4 - Life-threatening consequences, threats of harm to self or others; hospitalization
indicated
5 - Death
Diarrhoea
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
Refer to the NCI Criteria v4.03 (full version) for grading of any other symptoms seen
through the data collection period