Table 2: Regulatory status of the technology Country Organisation issuing approval Verbatim wording of the (expected) indication(s) (Expected) Date of approval (include expiry date for country of assessment) Launched (yes/no). If no include proposed date of launch Approval number (if available) Country of assessment Other countries
Example table 21: Frequency and severity of adverse events Study [insert study reference or identifier] System organ/ class/adverse events All grades Serious adverse events Death Intervention (n = x) n (%) Comparator (n = x) n (%) Relative risk (95% CI) Risk difference (95% CI) Intervention (n = x) n (%) Comparator (n = x) n (%) Relative risk (95% CI) Risk difference (95% CI) Intervention (n = x) n (%) Comparator (n = x) n (%) Relative risk (95% CI) Risk difference (95% CI) Class 1 (for example, nervous system disorders) Adverse event 1 Adverse event 2 Class 2 (for example, vascular disorders) Adverse event 3 Adverse event 4 CI, confidence interval Adapted from European Public Assessment Reports published by the European Medicines Agency From tables 3a and 5 of the EUnetHTA safety guideline
Table 22: Risk of bias at study level: randomised studies Study reference/ ID Adequate generation of a randomisation sequence Adequate allocation concealment Blinding Incomplete outcome reporting Selective outcome reporting unlikely? Overall risk of bias Patient Medical personnel (carer, investigator, outcome assessor) Yes/no/unclear Yes/no/unclear Yes/no/unclear Yes/no/unclear Yes/no/unclear Yes/no/unclear Low/high Note: an answer ‘yes’ indicates a low risk of bias, and an answer ‘no’ indicates high risk of bias If the answer is ‘unclear’ or ‘no’, please give reasons for the classification
Risk of bias at outcome level: randomised studies Include all outcomes included in the evidence synthesis. For each study outcome included in the evidence synthesis, state whether: the outcome assessor was blinded intention-to-treat (ITT) was appropriately implemented selective outcome reporting is unlikely the study is free from other (outcome-specific) aspects that affect the risk of bias. The information can be included in a table (see table 23). Table 23: Risk of bias outcome level for [outcome x] Study Blinding of outcome assessors ITT appropriately implemented Selective outcome reporting unlikely Is the study free of other outcome specific aspects that can affect the risk of bias Overall risk of bias Yes/ no/ unclear Yes/ no/ unclear Yes/ no/ unclear Yes/ no/ unclear Low / High Repeat the table for each outcome included in the evidence synthesis. Risk of bias: non-randomised studies Include all studies that were used in the evidence synthesis, including (if applicable) studies of comparator technologies. Include ongoing and unpublished studies if these data are available. Risk of bias assessment results can be displayed separately for each outcome. Therefore separate assessment of risk of bias at the outcome level is not required for non-randomised studies. For each non-randomised study identified, state whether there is:
Table 24: Risk of bias at study level: non-randomised studies Study reference/ ID Outcome Bias due confounding Bias in selection of patients into the study Bias in measurement of interventions Bias due to departures from intended interventions Bias due to missing data Bias in measurement of outcomes Bias in selection of the reported result Overall bias [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] NI=No information Insert reasons for the classification chosen