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We investigated acceptability by identifying time to completion, missing data and patients' qualitative comments about the instruments.
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Table 2 Number of patients completing PRO-CTCAE First PRO-CTCAE completion Second PRO-CTCAE completion Third PRO-CTCAE completion Fourth PRO-CTCAE completion Fifth PRO-CTCAE completion Total number of completions and missed completions Number of patients completing PRO-CTCAE 52 50 34 24 8 168 Number of patients with missed completion 2 3 0 1 0 6.
PHQ-9 questionnaires were completed on average 8 days from responding to the R-SMS-DS (range −8 to 75 days, completion date missing for 11 patients), and 213 patients (63 %) completed these outcomes within 6 days (Group 3).
Where necessary for completion of missing data, we contacted the parents and caregivers of the patients.
Revision of reactions refers to the completion of missing reaction participants.
Note that the baseline matrix completion is missing from the plot, as it cannot make predictions for diseases with no known entries.
The aggregated sampling frame for each country was subsequently sent to the corresponding focal person for validation and completion of missing information and positions.
No major or safety problems were detected; some minor corrections, for example completion of missing data, were instigated and problems with screening failures were discussed.
We consulted the clinical records of the hospital to which a woman had been referred for the completion of missing data (62 women).
Longitudinal outcomes will be analyzed on an intent to treat basis, including every subject who is randomized regardless of protocol adherence, study completion, or missing data.
Combining responses to adherence questionnaires completed by children or carers at each trial visit during the first 48 weeks (89% completion rate), missing a dose within 3 days of the clinic visit was only reported on 20 occasions [14 (3.5%) q.d. vs. 6 (1.5%) b.i.d., GEE logistic regression: P = 0.2].
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