This function creates the text and summary table for the report.
Value
- txt
The sentences required for the report
- tab
The summary table required for the report
- tab_map
Mapping between the variable name in
taband a nicer label
Examples
data(asr_sae)
# IMP
prepped <- asr_dataprep(asr_sae,
period_from = as.Date("2020-10-10"),
period_to = as.Date("2021-10-10")
)
asr_safety_summary(data = prepped$data, period_data = prepped$period_data,
"imp", 60, n_per_arm = list(grp1 = 150, grp2 = 150))
#> $txt
#> [1] "During the reporting period, 20 of 60 participants (33.3 %) reported a total of 20 serious adverse events (SAEs)."
#> [2] "5 of 20 SAEs (25.0 %) were classified 'related' to the IMP."
#> [3] "Most frequent related SAEs (i.e., SADR.) documented were poor sleep (2), spontaneous unconsciousness (2), headache (1)."
#> [4] "6 Suspected Unexpected Serious Adverse Reactions (SUSARs) occurred during the reporting period, which have been notified to the Swiss competent authorities."
#>
#> $txt_all
#> [1] "Since the beginning of the study, 20 of 60 participants (33.3 %) reported a total of 20 serious adverse events (SAEs)."
#> [2] "5 of 20 SAEs (25.0 %) were classified 'related' to the IMP."
#> [3] "Most frequent related SAEs (i.e., SADR.) documented were poor sleep (2), spontaneous unconsciousness (2), headache (1)."
#> [4] "6 Suspected Unexpected Serious Adverse Reactions (SUSARs) occurred during the reporting period, which have been notified to the Swiss competent authorities."
#>
#> $tab
#> # A tibble: 2 × 5
#> desc fatal sae sadr susar
#> <chr> <chr> <chr> <chr> <chr>
#> 1 Number of cases (during reporting period) N = … N = … N = … N = …
#> 2 Number of cases (cumulative) since the start of the c… N = … N = … N = … N = …
#>
#> $tab_map
#> col_key
#> 1 desc
#> 2 fatal
#> 3 sae
#> 4 sadr
#> 5 susar
#> name
#> 1 IMP
#> 2 Serious Adverse Events, SAEs, with fatal outcome
#> 3 Other Serious Adverse Events, non-fatal SAEs
#> 4 Serious Adverse Drug Reactions, SADRs (only for IMPs)
#> 5 Suspected Unexpected Serious Adverse Reactions, SUSARs (only for IMPs)
#>
# medical devices
prepped <- asr_dataprep(asr_sae, period_from = as.Date("2020-10-10"),
period_to = as.Date("2021-10-10"), trial_type = "m")
asr_safety_summary(data = prepped$data,
period_data = prepped$period_data, "m", 60,
n_per_arm = list(grp1 = NA, grp2 = NA))
#> $txt
#> [1] "During the reporting period, a total of 20 serious adverse events (SAEs) have been reported."
#> [2] "5 out of 20 SAEs (25.0 %) were classified ''related'' to the MD or to an intervention (procedure) undertaken in the clinical trial."
#> [3] "In 11 of 20 SAEs (55.0 %) it cannot be excluded that the events are attributable to the medical device under investigation."
#> [4] "In 7 of 20 SAEs (35.0 %) it cannot be excluded that the events are attributable to an intervention undertaken in the clinical trial."
#> [5] "The most frequent SAEs documented were spontaneous unconsciousness (7), headache (5), poor sleep (4)."
#> [6] "Occurrence of SAE in the trial arm versus control arm (if applicable)."
#> [7] "With respect to the expectedness of the event, 7 (35.0 %) of the SADEs were expected/anticipated and 13 (65.0 %) were classified as unexpected/unanticipated."
#> [8] "11 device deficiencies were observed (includes malfunctions, use errors, inadequacies in the information supplied by the manufacturer including labelling)."
#> [9] "11 out of 11 device deficiencies (100.0 %) could have led to serious adverse events if suitable action had not been taken, intervention had not been made, or circumstances had been less fortunate (device deficiencies with a SAE potential)."
#> [10] "12 health hazards that required safety-related measures occurred."
#> [11] "Safety and protective measures taken by the investigator/sponsor (including those requested by the ethics committee and Swissmedic and authorities abroad) taken in Switzerland and abroad: [free text]"
#>
#> $txt_all
#> [1] "During the reporting period, a total of 20 serious adverse events (SAEs) have been reported."
#> [2] "5 out of 20 SAEs (25.0 %) were classified ''related'' to the MD or to an intervention (procedure) undertaken in the clinical trial."
#> [3] "In 11 of 20 SAEs (55.0 %) it cannot be excluded that the events are attributable to the medical device under investigation."
#> [4] "In 7 of 20 SAEs (35.0 %) it cannot be excluded that the events are attributable to an intervention undertaken in the clinical trial."
#> [5] "The most frequent SAEs documented were spontaneous unconsciousness (7), headache (5), poor sleep (4)."
#> [6] "Occurrence of SAE in the trial arm versus control arm (if applicable)."
#> [7] "With respect to the expectedness of the event, 7 (35.0 %) of the SADEs were expected/anticipated and 13 (65.0 %) were classified as unexpected/unanticipated."
#> [8] "11 device deficiencies were observed (includes malfunctions, use errors, inadequacies in the information supplied by the manufacturer including labelling)."
#> [9] "11 out of 11 device deficiencies (100.0 %) could have led to serious adverse events if suitable action had not been taken, intervention had not been made, or circumstances had been less fortunate (device deficiencies with a SAE potential)."
#> [10] "12 health hazards that required safety-related measures occurred."
#> [11] "Safety and protective measures taken by the investigator/sponsor (including those requested by the ethics committee and Swissmedic and authorities abroad) taken in Switzerland and abroad: [free text]"
#>
#> $tab
#> # A tibble: 2 × 4
#> desc sade attr measures
#> <chr> <int> <int> <int>
#> 1 Number of cases (during reporting period) 0 11 12
#> 2 Number of cases (cumulative) since the start of the clin… 0 11 12
#>
#> $tab_map
#> col_key
#> 1 desc
#> 2 sade
#> 3 fatal
#> 4 sae
#> name
#> 1 MD/IVD Device
#> 2 Serious Adverse Device Effects SADE
#> 3 Device Deficiencies that could have led to an SAE (serious deficiencies)
#> 4 Safety and protective measures taken in Switzerland and abroad.
#>
# other trial
asr_safety_summary(data = prepped$data, period_data = prepped$period_data, "o", 60,
n_per_arm = list(grp1 = 150, grp2 = 150))
#> $txt
#> [1] "During the reporting period, 20 of 60 participants (33.3 %) reported a total of 20 serious adverse events (SAEs) with possible relationship to the study intervention)."
#> [2] "The most frequent documented SAEs with possible relationship to the intervention were poor sleep (2), spontaneous unconsciousness (2), headache (1)."
#>
#> $txt_all
#> [1] "Since the beginning of the study, 20 of 60 participants (33.3 %) reported a total of 20 serious adverse events (SAEs) with possible relationship to the study intervention)."
#> [2] "The most frequent documented SAEs with possible relationship to the intervention were poor sleep (2), spontaneous unconsciousness (2), headache (1)."
#>
#> $tab
#> # A tibble: 2 × 3
#> desc fatal nfatal
#> <chr> <chr> <chr>
#> 1 Number of cases (during reporting period) N = … N = 5…
#> 2 Number of cases (cumulative) since the start of the clinical tri… N = … N = 4…
#>
#> $tab_map
#> col_key
#> 1 desc
#> 2 fatal
#> 3 sae
#> name
#> 1 Other clinical trial
#> 2 SAEs with fatal outcome where a causality to the intervention cannot be excluded
#> 3 Other SAEs where a causality to the intervention cannot be excluded
#>
# tpr trial
asr_safety_summary(data = prepped$data, period_data = prepped$period_data, "t", 60,
n_per_arm = list(grp1 = 150, grp2 = 150))
#> $txt
#> [1] "During the reporting period, a total of 20 Serious Adverse Events (SAEs) occurred."
#> [2] "5 of 20 SAEs (25.0 %) were classified as Serious Adverse Drug Reaction (SADR) i.e., serious adverse events with possible relationship to the TrP/GT/GMO administered."
#> [3] "The most frequent SADR documented were spontaneous unconsciousness (7), headache (5), poor sleep (4)."
#> [4] "In 1 out of 5 SADRs (20.0 %) it cannot be excluded that the events are attributable to the TrP/GT/GMO itself."
#> [5] "In 4 out of 5 SADRs (80.0 %) it cannot be excluded that the events are attributable to other factors like quality defects, contaminations, administration and preparation procedures of TrP/GT/GMO, etc."
#> [6] "6 Suspected Unexpected Serious Adverse Reactions (SUSARs) occurred during the reporting period."
#> [7] "Other new relevant safety aspects (including details regarding exposure): "
#>
#> $txt_all
#> [1] "Since the beginning of the study, a total of 20 Serious Adverse Events (SAEs) occurred."
#> [2] "5 of 20 SAEs (25.0 %) were classified as Serious Adverse Drug Reaction (SADR) i.e., serious adverse events with possible relationship to the TrP/GT/GMO administered."
#> [3] "The most frequent SADR documented were spontaneous unconsciousness (7), headache (5), poor sleep (4)."
#> [4] "In 1 out of 5 SADRs (20.0 %) it cannot be excluded that the events are attributable to the TrP/GT/GMO itself."
#> [5] "In 4 out of 5 SADRs (80.0 %) it cannot be excluded that the events are attributable to other factors like quality defects, contaminations, administration and preparation procedures of TrP/GT/GMO, etc."
#> [6] "6 Suspected Unexpected Serious Adverse Reactions (SUSARs) occurred during the reporting period."
#> [7] "Other new relevant safety aspects (including details regarding exposure): "
#>
#> $tab
#> # A tibble: 2 × 6
#> desc fatal nfatal nsadr sadr susar
#> <chr> <chr> <chr> <chr> <chr> <chr>
#> 1 Number of cases (during reporting period) N = … N = 5… N = … N = … N = …
#> 2 Number of cases (cumulative) since the start o… N = … N = 1… N = … N = … N = …
#>
#> $tab_map
#> col_key name
#> 1 desc
#> 2 fatal SAEs with fatal outcome
#> 3 nfatal Other Serious Adverse Events (non-fatal SAEs)
#> 4 nsadr Non-Serious Adverse Drug Reactions, NSADRs
#> 5 sadr Serious Adverse Drug Reactions, SADRs
#> 6 susar Suspected Unexpected Serious Adverse Reactions, SUSARs
#>