| Question Text | Prompt | Type | CDASH Variable Name | SDTM Variable Name | Case Report Form completion instructions | Mapping Instructions | Implementation Instructions | Permissible Values | Pre-populated Value | Hidden |
|---|
| N/A | N/A | text | CETERM | CETERM |
| Maps directly to SDTM. | Not typically entered by an investigative site. May appear as a label or header on the case report form. |
| Hypoglycemic Event | hidden |
| N/A | N/A | text | CECAT | CECAT |
| Maps directly to SDTM. | Not typically entered by an investigative site. May appear as a label or header on the case report form. |
| HYPO EVENTS | hidden |
| Any Hypoglycemic Events Experienced? | Any Hypoglycemic Events Experienced? | boolean | CEYN | N/A | Indicate whether or not any hypoglycemic events occurred. | This variable does not map to SDTM. | Primary intent/purpose of field is to help with data cleaning and monitoring. |
|
|
|
| Sponsor Defined ID |
| text | CESPID | CESPID |
|
| Can be pre-populated Row or Sequence Number to Identify Event (SPID). |
|
|
|
| Date of Event |
| date | CESTDAT | CESTDTC | Record start date using DD-MMM-YYYY format. | For SDTM-based dataset, SDTMIG variable CESTDTC is derived by concatenating CDASH Start Date (CESTDAT) and Time (CESTTIM if time is collected) and converting to ISO 8601 format.
For more detail see the CDASH v1.1 Best Practice section.
This field does not map directly into SDTM. | CDASH recommends the unambiguous format DD-MMM-YYYY where “DD” is a 2-digit numeric value for day, “MMM” is a 3-character letter abbreviation for month, and “YYYY” is a 4-digit numeric value for year. |
|
|
|
| Time of Event |
| date | CESTTIM | CESTDTC | Record time using a 24 hour clock. | For SDTM-based dataset, SDTMIG variable CESTDTC is derived by concatenating CDASH Start Date (CESTDAT) and Time (CESTTIM if time is collected) and converting to ISO 8601 format.
For more detail see the CDASH v1.1 Best Practice section.
This field does not map directly into SDTM. |
|
|
|
|
| When Did the Hypoglycemic Event Occur? |
| text | WHENOCC | QVAL | Record the time period during which the hypoglycemic event occurred. | QVAL when QNAM= WHENOCC and
QLABEL= "When Did the Hypoglycemic Event Occur?". | Recommend response choices: "Between Bedtime and Waking" and "Between Waking and Bedtime". | Between Bedtime and Waking; Between Waking and Bedtime |
|
|
| In the Opinion of the Investigator Was This an Adverse Event? | Y/N | boolean | WASAEYN | FAORRES | Indicate whether or not the investigator has determined this to be an adverse event. | The response will map to FAORRES where FATESTCD= "WASAEYN", FATEST= "Was this an adverse event?" and FAOBJ="HYPOGLYCEMIC EVENT". |
|
|
|
|
| Was a Glucose Measurement Obtained at the Time of the Event? | Y/N | boolean | LBPERF | LBSTAT | Indicate whether or not glucose measurement obtained. If yes, enter result and unit below. | "Yes" response is not submitted. "No" is mapped to LBSTAT as the value "NOT DONE".
In LB domain, LBTESTCD will be "GLUC", LBTEST will be "GLUCOSE" and a value must be assigned to LBCAT to distinguish this from other results. | Primary intent/purpose of field is to help with data cleaning and monitoring.
The sponsor may map a response of "No" as directed to document testing that was not performed. A response of "Yes" will not be mapped to the SDTM data.
Because this field does not map to an SDTM domain, the sponsor may assign a naming prefix according to internal conventions. |
|
|
|
| Glucose Result | float | LBORRES | LBORRES | Enter result value. |
| "xxx.xx" for result |
|
|
|
| Glucose Units | text | LBORRESU | LBORRESU | Enter the unit related to the result value. |
| Expected values for Glucose Result Units are "mg/dL" or "mmol/L". |
|
|
|
| N/A | N/A | text | ECCAT or EXCAT | ECCAT or EXCAT |
|
|
|
| HIGHLIGHTED DOSE | hidden |
| Last Study Medication Taken | Name/Reference | text | ECTRT or EXTRT | ECTRT or EXTRT | Enter the name or reference to the last study medication taken. | Map ECTRT to EXTRT as discussed in the SDTMIG. | Collection of the data related to Last Medication Taken is Optional.
Medication label can be pre-populated in question text, and section can be repeated if multiple labels .
EXCAT= HIGHLIGHTED DOSE required to differentiate EX records added exclusively for hypoglycemic reference. Though this value will not typically be included as a field for entry, it may be preprinted on the CRF.
If collected, the sponsor should use variables from the EC or EX domain as appropriate for the CDISC implementation by sponsor. |
|
|
|
| Date | date | ECSTDAT or EXSTDAT | ECSTDTC or EXSTDTC | Record the date of the last study medication taken using DD-MMM-YYYY format. |
| Optional to include if Last Medication Taken is collected. |
|
|
|
| Time | date | ECSTTIM or EXSTTIM | ECSTDTC or EXSTDTC | Record the time of the last study medication taken using a 24 hour clock. |
| Optional to include if Last Medication Taken is collected. |
|
|
|
| Dose | float | ECDSTXT or EXDSTXT | ECDOSE or EXDOSE | Record the dose of the last study medication taken. |
| Include if Last Medication Taken is also collected. |
|
|
|
| Units | text | ECDOSU or EXDOSU | ECDOSU or EXDOSU | Record the units associated with the dose. |
| Include if Last Medication Taken Dose is collected. May be printed. |
|
|
|
| N/A | N/A | text | HYPOMED_CMCAT | CMCAT |
|
|
|
| ANTI-HYPERGLYCEMIC MED | hidden |
| N/A | N/A | text | CMSCAT | CMSCAT |
|
|
|
| HIGHLIGHTED DOSE | hidden |
| Last Concomitant Diabetic Medication Taken | Name/Reference | text | CMTRT | CMTRT | Enter the name or reference to the last concomitant diabetic medication taken |
| Collection of the data related to Last Concomitant Diabetic Medication Taken is Optional.
Medication(s) of interest can be pre-populated in question text. Optional implementation would utilized a sponsor ID from CM entry to identify medication name/dose/units and only capture date/time of last dose.
CMCAT= ANTI-HYPERGLYCEMIC MED and CMSCAT = HIGHLIGHTED DOSE required to differentiate CM records added exclusively for hypoglycemic reference. Though this value will not typically be included as a field for entry, it may be preprinted on the CRF. |
|
|
|
| Date | date | CMSTDAT | CMSTDTC | Record date using DD-MMM-YYYY format. |
| Include if Last Concomitant Diabetic Medication Taken is also collected. |
|
|
|
| Time | date | CMSTTIM | CMSTDTC | Record time using a 24 hour clock. |
| Include if Last Concomitant Diabetic Medication Taken is also collected. |
|
|
|
| Dose | float | CMDSTXT | CMDOSE |
|
| Include if Last Concomitant Diabetic Medication Taken is also collected. |
|
|
|
| Units | text | CMDOSU | CMDOSU |
|
| Include if Last Concomitant Diabetic Medication Taken Dose is also collected. |
|
|
|
| Date of Last Meal | Date | date | MLSTDAT | MLSTDTC | Record using DD-MMM-YYYY format. |
|
|
|
|
|
| Time of Last Meal | Time | date | MLSTTIM | MLSTDTC | Record time using a 24 hour clock. |
|
|
|
|
|
| N/A | N/A | text | SYMPTOMS_CECAT | CECAT |
|
|
|
| HYPO SYMPTOMS | hidden |
| Were Signs/Symptoms Present? (If yes complete following) | Y/N | boolean | CEYN | N/A |
| Findings about the Hypoglycemic Event. Does not map to SDTM.
| If this question is used, then for the following signs/symptoms, it is possible to use checkboxes or only yes responses.
If this question is not used, then both yes and no responses must be collected for each item listed.
Sponsor to decide if only "Yes" responses retained in SDTM. |
|
|
|
| Sweating | boolean | SWEATING_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Sweating" will populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Tremors/Trembling | boolean | TREMORS_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Tremors/Trembling" will populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Dizziness | boolean | DIZZINESS_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Dizziness" will be used to populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Cognitive Impairment | boolean | COGNITIVE_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Cognitive Impairment" will be used to populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Loss of Consciousness | boolean | LOC_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Loss of Consciousness" will be used to populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Convulsions/Seizure | boolean | SEIZURE_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Convulsions/Seizure" will be used to populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Coma | boolean | COMA_CEOCCUR | CEOCCUR |
| If response is Y, the prompt "Coma" will be used to populate SDTM variable CETERM. CEPRESP will be populated as "Y". CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Other (Specify) | boolean | OTHER_CEOCCUR | CEOCCUR; |
| If response is Y, the value entered for the Specify field will be used to populate CETERM. CEPRESP will be null. CECAT will be populated as "HYPO SYMPTOMS". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion. |
|
|
|
| Specify Other | text | OTHER_CETERM | CETERM | If Other (Specify) is yes, specify the other sign/symptom |
|
|
|
|
|
| N/A | N/A | text | FACAT | FACAT |
|
|
|
| PRECIPITATING FACTORS | hidden |
| N/A | N/A | text | FAOBJ | FAOBJ |
|
| FAOBJ = HYPOGLYCEMIC EVENT; number consecutively. |
| HYPOGLYCEMIC EVENT | hidden |
| Were Any Precipitating Factors Reported? | Y/N | boolean | HPFYN | N/A |
| Findings about the Hypoglycemic Event. Does not map to SDTM. | If this question is used, then for the following precipitating factors, it is possible to use checkboxes or only yes responses.
If this question is not used, then both yes and no responses must be collected for each item listed.
Sponsor to decide if only "Yes" responses retained in SDTM. |
|
|
|
| Alcohol Consumption | boolean | ALCPF_FAORRES | FAORRES |
| The prompt "Alcohol Consumption as a Precip Factor" will be used to populate SDTM variable FATEST. FACAT will be populated as "PRECIPITATING FACTORS". FAOBJ will be populated as "HYPOGLYCEMIC EVENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Concurrent Illness | boolean | ILLPF_FAORRES | FAORRES |
| The prompt "Concurrent Illness as a Precip Factor" will be used to populate SDTM variable FATEST. FACAT will be populated as "PRECIPITATING FACTORS". FAOBJ will be populated as "HYPOGLYCEMIC EVENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Deviation from Dosing Instructions | boolean | DSDVPF_FAORRES | FAORRES |
| The prompt "Dosing Deviation as a Precip Factor" will be used to populate SDTM variable FATEST. FACAT will be populated as "PRECIPITATING FACTORS". FAOBJ will be populated as "HYPOGLYCEMIC EVENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Missed, Delayed or Smaller Meal | boolean | MEALPF_FAORRES | FAORRES |
| The prompt "Meal Variance as a Precip Factor" will be used to populate SDTM variable FATEST. FACAT will be populated as "PRECIPITATING FACTORS". FAOBJ will be populated as "HYPOGLYCEMIC EVENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Physical Activity | boolean | PAPF_FAORRES | FAORRES |
| The prompt "Physical Activity as a Precip Factor" will be used to populate SDTM variable FATEST. FACAT will be populated as "PRECIPITATING FACTORS". FAOBJ will be populated as "HYPOGLYCEMIC EVENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Other (Specify) | boolean | OTHPF_FAORRES | FAORRES |
| If response is Y, the value in the Specify field will be used to populate SDTM variable FATEST. (Alternately, "Other" concatenated with the data in the Specify field may be used to populate FATEST.) FATESTCD will be "OTHER". FAOBJ will be populated as "HYPOGLYCEMIC EVENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Specify Other | text | OTHPF_FATEST | FATEST | If Other (Specify) is yes, specify the other precipitating factor. |
|
|
|
|
|
| N/A | N/A | text | HTG_CMCAT | CMCAT |
|
|
|
| HYPO TREATMENT | hidden |
| Was Any Treatment Given for the Hypoglycemic Event? (If yes complete following) | Y/N | boolean | HTGYN | N/A |
| Question used for data cleaning and does not map to SDTM. | On the annotated CRF, note as Not Submitted. If sponsor elects to submit this response recommend using CECONTRT. |
|
|
|
| Drink | boolean | DRINK_CMOCCUR | CMOCCUR |
| If response is Y, the prompt "Drink" will be used to populate SDTM variable CMTRT. CMPRESP will be Y. CMCAT will be "HYPO TREATMENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Food | boolean | FOOD_CMOCCUR | CMOCCUR |
| If response is Y, the prompt "Food" will be used to populate SDTM variable CMTRT. CMPRESP will be Y. CMCAT will be "HYPO TREATMENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Glucose Tablets | boolean | TABLET_CMOCCUR | CMOCCUR |
| If response is Y, the prompt "Glucose Tablets" will be used to populate SDTM variable CMTRT. CMPRESP will be Y. CMCAT will be "HYPO TREATMENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Glucagon Injection | boolean | INJECT_CMOCCUR | CMOCCUR |
| If response is Y, the prompt "Glucagon Injection" will be used to populate SDTM variable CMTRT. CMPRESP will be Y. CMCAT will be "HYPO TREATMENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| Intravenous Glucose | boolean | IV_CMOCCUR | CMOCCUR |
| If response is Y, the prompt "Intravenous Glucose" will be used to populate SDTM variable CMTRT. CMPRESP will be Y. CMCAT will be "HYPO TREATMENT". | Expected responses are Y or N. Yes responses will result in a record in SDTM. Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. |
|
|
|
| If Treatment Given Indicate Assistance Needed? | Need for Assistance | text | FAORRES | FAORRES | Investigator assessment. | FACAT will be populated as "TREATMENT ADMINISTRATION". FATESTCD= "TXASSIST", FATEST="Treatment Assistance", FAOBJ will be populated as "HYPOGLYCEMIC EVENT" concatenated with consecutive numbers to differentiate between groups of findings when multiple events are reported. | The sponsor may choose to collect responses to this question only if treatment for the hypoglycemic event is given.
The expected responses are "None - Subject Treated Self", "Subject was Capable of Treating Self, but Received Assistance" and "Subject was Not Capable of Treating Self, and Required Assistance". | None - Subject Treated Self; Subject was Capable of Treating Self, but Received Assistance; Subject was Not Capable of Treating Self, and Required Assistance |
|
|