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Table 2 PRO-CTCAE questions and threshold for on-screen alert for intervention arm

From: The iBLAD study: patient-reported outcomes in bladder cancer during oncological treatment: a multicenter national randomized controlled trial

Symptom

nb

Symptom

Items

Alert threshold PRO-CTCAE grade

Alert wording

Number of questions

Grade threshold yellow/red

1

Decreased appetite

Severity

2

2:*

1

2/ > 2

  

Interference with daily activities

2

2:*

2

2/ > 2

2

Nausea

Frequency

1 + 2

1: If you have been given anti-emetics that you haven’t applied, please take them now. If in doubt, please contact the department 2: *

3

2/ > 2

  

Severity

1 + 2

1: If you have been given anti-emetics that you haven’t applied, please take them now. If in doubt, please contact the department

2:*

4

2/ > 2

3

Vomiting

Frequency

1 + 2

1: If you have been given anti-emetics that you haven’t applied, please take them now. If in doubt, please contact the department

2: *

5

2/ > 2

  

Severity

1 + 2

1: If you have been given anti-emetics that you haven’t applied, please take them now. If in doubt, please contact the department

2: *

6

2/ > 2

4

Constipation

Severity

1 + 2

1: If you have laxative medications at home but are in doubt of how to apply them, please contact the department 2:*

7

2/ > 2

5

Diarrhea

Frequency

1

1:*

8

2/ > 2

6

Shortness of breath

Severity

2**

2:*

9

2/ > 2

  

Interference with daily activities

2**

2:*

10

2/ > 2

7

Swelling

Frequency

2

2:*

11

2/ > 2

  

Severity

2

2:*

12

2/ > 2

  

Interference with daily activities

2

2:*

13

2/ > 2

8

Heart palpitations

Frequency

2

2:*

14

2/ > 2

  

Severity

2

2:*

15

2/ > 2

9

Itching

Severity

2

2:*

16

 > 1

10

Pain

Frequency

1 + 2

1: If you have pain medication at home and have doubts of how to apply them, please call the department

2: *

17

2/ > 2

  

Severity

1 + 2

1: If you have pain medication at home and have doubts of how to apply them, please call the department

2: *

18

2/ > 2

  

Interference with daily activities

1 + 2

1: If you have pain medication at home and have doubts of how to apply them, please call the department

2: *

19

2/ > 2

11

Insomnia

Severity

2

2:*

20

2/ > 2

  

Interference with daily activities

2

2:*

21

2/ > 2

12

Fatigue

Severity

3

3:*

22

2/ > 2

  

Interference with daily activities

3

3:*

23

2/ > 2

13

Anxiety

Frequency

2

2:*

24

2/ > 2

  

Severity

2

2:*

25

2/ > 2

  

Interference with daily activities

2

2:*

26

2/ > 2

14

Frequent urination

Frequency

3

3:*

27

3/ > 3

  

Interference with daily activities

3

3:*

28

3/ > 3

15

Chills

Frequency

1

1:*

29

2/ > 2

  

Severity

1

1:*

30

2/ > 2

  1. *: Please contact the department at which you’re treated. Remember to complete the rest of the questionnaire, even though you contact the department. **: or at deterioration from baseline