Table 2

Set of predefined rules to trigger an alert

SymptomRules for alert
PRO-CTCAE symptoms
Decreased appetite1. If the symptom reaches grade 3
  • a. The symptom has not reached a grade 3 in the last 2 weeks (<15 days)

  • b. If the symptom stays a stable grade 3 for 4 consecutive weeks, the fourth week will provide the next alert


2. If the symptom worsens by ≥2 grades
  • a. in 2 weeks

  • b. if the checklist has not been filled in for 4 consecutive weeks

Cough
Shortness of breath
Fatigue
Constipation
Nausea
Diarrhoea
Sad or unhappy feelings
General pain
Other symptoms
Fever3. If ‘yes’ is scored (independent of earlier reports about fever)
Haemoptysis4. If ‘a little’ or ‘a lot’ is scored (independent of earlier reports about haemoptysis)
Weight5. Loss of weight ≥3 kg in 1 or 2 weeks
  • a. If the questionnaire was not filled-in for 4 consecutive weeks a loss of weight of ≥3 kg since the last measurement will also summon an alert

  • b. Patient has scored ‘I did not weight myself’ is seen as rule 5a

  • PRO-CTCAE, Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events.