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Table 2 Visit and assessment schedule

From: Clinical and virological outcomes with baloxavir compared with oseltamivir in pediatric patients aged 6 to < 12 years with influenza: an open-label, randomized, active-controlled trial protocol

Day

1

2 +1 day

3

4

5

-1 to +2 days

6

7

8

9

10

−1 to +4 days

4

Discontinuation +14 days

Visit

1a

2

3

Pre dose

Post dose

Informed consent

X

           

Inclusion/exclusion criteria

X

           

Demographics, clinical characteristics, and medical history

X

           

Enrollment and randomization

X

           

Baloxavir administration

 

X

          

Oseltamivir administration

 

X

X

X

X

X

      

Diary (ePRO)

            

Body temperature

X

Xa

qid

bid

  

Influenza symptom severity

X

Xa

bid

  

Medical examinationb

X

 

X

  

X

    

X

X

Vital signs

X

 

X

  

X

    

X

X

Influenza RIDT

Xc

           

SARS-CoV-2 test

Xd

 

Xe

         

Influenza virus tests (RT-PCR, titer, RNA, PA, or NA sequence)

X

 

X

  

X

    

X

X

Influenza virus serum antibody titer test (HI method)

X

           

Intrahousehold influenza infection rate questionnaire

          

X

X

TEAE reporting

X

X

X

X

X

X

X

X

X

X

X

X

  1. X denotes assessment to be undertaken
  2. bid twice a day; COVID-19 coronavirus disease 2019; ePRO electronic patient-reported outcome; HI hemagglutination inhibition; NA neuraminidase; PA polymerase acidic protein; qid four times a day; RIDT rapid influenza diagnostic test; RT-PCR reverse transcription-polymerase chain reaction; SARS-CoV-2 severe acute respiratory syndrome coronavirus 2; TEAE treatment-emergent adverse event
  3. aNot measured if study drug taken after 18:00
  4. bParticipants’ height and body weight are measured on Day 1 (predose/screening)
  5. cParticipants who have an RIDT and/or other influenza virus test within 48 h of symptom onset but before written informed consent do not need to take an RIDT and/or other influenza virus test on Day 1
  6. dParticipants who are determined to be SARS-CoV-2 negative according to the COVID-19 clinical guideline in Japan (https://www.mhlw.go.jp/content/000712473.pdf) before giving written consent do not need to undergo a SARS-CoV-2 test on Day 1
  7. eThis test will be conducted according to the COVID-19 clinical guideline as appropriate