WHO central database for collection of safety data (AE and/or SAE) in the scope of adsm of anti-tb drugs Variables to be collected ID case number CONTR Case ID number Case identification number in national database. Automated consecutive number generated by national database AEID Local Adverse Event Local identifier for adverse event (optional) identifier AEWID Worldwide unique case identification number International unique AE case identifier for the ICSR. If case was not assigned an international unique AE case identifier, leave blank. FACILIT INFORMATION CONTR Country Country of the primary source SITEM Facility name Name of the primary source SITEID Site identifier Site ID number PATIENT IDENTIFIER AND DEMOGRAPHICS SBJID ID number Patient ID number in country database. SEX Sex Patient s gender F Female M Male nknown BRTHDTC of birth Birth date in format (DD-MON-). Full birth date shoudl only be transferred to central database is allowed by regulation. Page 1 of 7
PATIENT DETAILS AT THE TIME OF THE EVENT SAEAGE Patient onset age Age of the patient at the time of the AE/SAE onset Num ### HEIGHT Height Patient height in cm (rounded, with no decimals) Num ### WEIGHT Weight Patient weight in kg (rounded, with no decimals) Num ### PCONFIND Pregnancy status at Indicates whether the patient was pregnant at the time of the onset of AE/SAE. N No start of event nknown es LMPSTDTC If pregnant, date of LMP Start date of last Menstrual Period (The first day of the most recent menstrual cycle) (DD-MMM-) can be stored as 3 different fields (days, months, year) to simplify management of partial date. Estimated Gestational Age (expressed in weeks) at start of the event (an approximate EGESTAGE If pregnant, gestation Num week at start of event calculation of the gestational age of the Fetus at start of the event). HIVST HIV Status Indicates HIV status at the time of the AE onset 1 Negative 2 Positive 3 nknown AE/SAE DESCRIPTION AETERM1 Adverse Events Description Verbatim (i.e., investigator-reported term) description of the adverse event AETERM2 Adverse Events Verbatim (i.e., investigator-reported term) description of the adverse event in English (if Description (in English) AETERM1 is not in English) AEDECOD Adverse event Dictionary-derived text description of AETERM. Equivalent to the Preferred Term (PT in MedDRA). Page 2 of 7
AESTDTC of AE onset Start date of the AE/SAE using this format (DD-MON-). AEENDTC Event End date AE/SAE stop date. that the AE resolved or led to death using this format (DD-MON- ). If the AE is ongoing, this field should be blank. AETOXGR ** Intensity Maximum grade of the intensity of the AE Num 1 Grade 1 (Mild) 2 Grade 2 (Moderate) 3 Grade 3 (Severe) 5 nkown AEACN1 Action taken Action taken to manage the AE/SAE Num 1 Drug reduced or stopped AEOT Outcome Outcome of the event in relation to the subject s status. 2 Administration of treatment to treat the ae/sae 3 Hospitalisation 4 None 5 nknown 1 Death related to AE Select Death Related to Adverse Event for The termination of life as a result of an adverse event. 2 Not recovered/not resolved Select Not Recovered or Not Resolved to indicate that the event has not 3 Recovered/resolved improved or recuperated. 4 Recovered/resolved Select Recovered or Resolved if the event has improved or recuperated. with sequelae Select Recovered or Resolved with Sequelae if the subject recuperated but Recovering/resolving retained pathological conditions resulting from the prior disease or injury. 5 Select Recovering or Resolving if the event is improving but has not yet fully 6 recovered nknown Select nknown if the outcome was not known, not observed or not recorded AESER Event classified as Indicates whether or not the adverse event is determined to be serious. N No Serious nknown es AESTDTH Death If SAE is it: Death? Indicates if a serious adverse event resulted in death. N No nknown es APERF Autopsy In case of death: Was an autopsy done? N No Page 3 of 7
nknown es AESLIFE Life Threatening If SAE is it: Life Threatening? Indicates if a serious adverse event was life threatening. N No nknown es AESHOSP Hospitalisation If SAE is it: Hospitalisation required or prolonged hospitalisation? Indicates if a serious N No adverse event resulted in an initial or prolonged hospitalization. nknown es AESDISAB Disability If SAE is it: Persistent/significant disability? Indicates if a serious adverse event was N No associated with a persistent or significant disability or incapacity. nknown es AESCONG Congenital If SAE is it: Congenital anomaly/birth defect? Indicates if a serious adverse event was N No anomaly/birth defect associated with a congenital anomaly or birth defect. nknown es AESMIE Other medical If SAE is it: Other medical event considered as important? Indicates if a serious N No important event adverse event is associated with other serious or important medical events. nknown es AEREPORT Report to national PV Indicates if the event was reported to the national pharmacovigilance center N No center nknown es COVAL Narrative / Additional Additional comment (free text) Text information NLN Do you wish to mark This item should be used to indicate that a safety case previously recorded should be N No this safety case as considered completely void (nullified), for example when the whole case was found to be ;nknown nullified? erroneous. es NLREAS Why are you nullifying the safety case? Reason for nullification ** AETOXGR: lookup values for this variable can be modified by the site Page 4 of 7
MEDICAL TREATMENTS (MDR-TB REGIMEN and concomitant treatments) The treatment to be reported is the one taken by the patient at the time the AE/SAE occurred EXCOLLECT Drug name Name of the treatment as originally received or collected. Commercial name if possible, otherwise use generic name. EXTRT Code for drug name Name of the treatment in a coded format defined ( use by consistant wiht the one listed in the Site description form) EXDOSE Daily dose Total dose taken per day Num EXDOS Dose unit nit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg) EXDOSFRQ EXROTE EXROTESP (#) Frequency (as days per weeks) Route of administration Route of administration Frequency the treatment was administered in days per week Num Record the route of administration (e.g., IV, ORAL, TRANSDERMAL) 1 Oral 2 Intramuscual 3 Intravenous 4 Subcutenaous 5 Transdermal 6 Topical 7 Vaginal 8 Rectal 9 Other 10 nknown If other, specify EXSTDTC Drug start date when administration of the treatment began using this format (DD-MON- ). Can be stored as 3 different fields (days, months, year) to simplify management of partial date. EXENDTC Drug stop date when administration of the treatment ended using this format (DD-MON- ). Can be stored as 3 different fields (days, months, year) to simplify management of partial date. EXONGO Drug still ongoing Indicates if the drug is still ongoing. It is expected that every reported drug should have either an End or the Ongoing field marked yes, but not both. N No nknown es Page 5 of 7
AEACN2 AERELRS ** AERELCL AEOTN Action taken with drug after AE/SAE Relationship of the drug to the AE/SAE (evaluation made by reporting site) Relationship of the drug to the AE/SAE (evaluation made at country central level) Response to dechallenge Changes made to the drug in response to the adverse event. 1 Dose increased Reporting site's opinion as to the causal relationship between the drug and the adverse event Records the central level opinion as to the causal relationship between the drug and the adverse event 2 Dose not changed 3 Dose reduced 4 Drug interrupted 5 Drug withdrawn 6 Not applicable 7 nknown 1 Certain 2 Probable/Likely 3 Possible 4 nlikely 5 Conditional/nclassified 6 nassessable/nclassifiable 7 nknown 1 Certain 2 Probable/Likely 3 Possible 4 nlikely 5 Conditional/nclassified 6 nassessable/nclassifiable 7 nknown Did the event improve after stopping/ reducing the dose reduced? N No nknown es EXREINTR Rechallenge Was the drug reintroduced? N No nknown es RECRN Response to Did the event reappear after rechallenge? Event recurrence on drug readministration. N No rechallenge nknown indicates that a rechallenge was done but it is not known if the event recurred. nknown es ** AERELRS: lookup values for this variable can be modified by the site depending (#) EXROTESP: Rather than creating this field, the site has the possibility to add more look up variables under the field EXROTESP Page 6 of 7
MEDICAL HISTOR MHN MHTERM1 MHTERM2 MHDECOD MHONGO Concurrent medical disorder If yes specify (in local language) If yes specify (in English) Coding for medical condition Is the medical condition still ongoing? Record if there were any relevant past and/or concomitant medical conditions or surgeries, present at the onset of the AE/SAE that may constitute a possible cause or a risk factor? Describe the relevant past and/or concomitant medical conditions or surgeries, present at the onset of the AE/SAE and that may constitute a possible cause or a risk factor. In language used in local database. Record all relevant past and/or concomitant medical conditions or surgeries, present at the onset of the AE/SAE and that may constitute a possible cause or a risk factor. In English. Dictionary-derived text description of MHTERM. Equivalent to the Preferred Term (PT in MedDRA). N No nknown es Indicate if the medical condition is still ongoing at the time of teh onset of the AE/SAE N No nknown es LABORATOR ASSESSMENT Results of tests and procedures relevant to the investigation of the patient LBTEST What is the lab test Indicate test name of the lab test performed for the investigation of the patient name? LBDTC when lab test is of test in format (DD-MON-). done LBORRES Result Result of the measurement or finding, as originally received or collected. Num LBORRES nit nits LBORNRLO Normal low range Lower Limit Normal Num LBORNRHI Normal high range pper Limit Normal Num Page 7 of 7