Missing endpoint measurement |
Assessment missing due to a participant’s premature discontinuation from the study overall for pandemic-related reasons;
Assessment missing due to missed study visits/procedures while a participant remains in the study (intermittent missing data);
Assessment delayed (out-of-window) and deemed unusable for an analysis;
A composite score (e.g., ACR20 in rheumatoid arthritis) cannot be calculated because some components are missing;
Assessment deemed to be influenced by pandemic-related factors and deemed unusable for a particular analysis because the interpretability of the results may be impacted (e.g., in assessments of quality of life, activity/functional scales, healthcare utilization, etc.);
Recorded data cannot be properly verified or adjudicated due to COVID-19-related factors and deemed to be unreliable for analysis;
Assessment performed after an intercurrent event intended to be handled with a hypothetical strategy and collected data are deemed unusable for this estimand.
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Assessment accessibility |
Site (facilities or staff) unavailable to perform study-related assessments;
Site/assessment procedure available but participant is unable/unwilling to get assessment done due to personal pandemic-related reasons.
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Participant’s COVID-19 infection condition |
Participant positive for COVID-19 and alive;
Participant deceased due to COVID-19;
Participant without a known COVID-19 infection.
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Participant’s COVID-19 concomitant treatment(s) |
Participants treated for COVID-19 (pharmacologically, oxygen, etc.);
Hospitalized, not in intensive care;
Admitted to intensive care.
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