Form: Adverse Events
| Question | Response |
|---|---|
| Adverse Event Verbatim | |
| Event Category | |
| Did the event start before administering first dose of study medication? | |
| Date Started | |
| Event ongoing? | |
| Date Ended | |
| Severity of the Event | |
| Event Related to Study Drug | |
| Toxicity Grade of the Event (CTCAE) | |
| Action Taken with Study Drug because of Adverse Event | |
| Other action taken? | |
| Serious Event? | |
| Resulted in Death? | |
| Immediately Life Threatening? | |
| Required Hospitalization or Prolonged Hospitalization? | |
| If hospitalized, | |
| date of hospitalization | |
| Time of hospitalization | |
| If hospitalized, | |
| date of discharge | |
| Time of discharge | |
| Persistent or Significant Disability? | |
| Congenital Anomaly/Birth Defect? | |
| Other Medically Important Serious Event? | |
| Outcome of the Event? | |
| Was the event adjudicated | |
| Adjudication Result | |
| Relationship to Non-Study Treatment |
Form: Falls
| Question | Response |
|---|---|
| Did the patient fall since last visit? | |
| Date of fall | |
| Time of the day | |
| Environment (of fall) | |
| Activity at the time of fall | |
| Fall Mechanism | |
| Did the fall result in injury | |
| Severity of the injury | |
Form:
| Question | Response |
|---|---|
| Did subject have any hypoglycemic events since the last visit? | |
| Sequence Identifier | |
| Hypoglycemic event start date | |
| Hypoglycemic event start time | |
| What was the date of last study treatment before the event? | |
| What was the time of last study treatment before the event? | |
| What was the subject's awareness of the hypoglycemic event? | |
| Blood glucose concentration measured prior to treating the event? | |
| If measured, what is the blood glucose concentration | |
| Unit of blood glucose concentration measurement | |
| Were signs/symptoms of hypoglycemia present, other than the blood glucos | |
| What was the hypoglycemic event outcome? | |
| Specify if outcome is other | |
| Was treatment given because of the occurrence of the event? | |
| If yes, how was the hypoglycemic event treatment | |
Form: Hepatobiliary assessment form
| Question | Response |
|---|---|
| Adverse Event Identifier | |
| Has the subject recently received a blood transfusion or traveled to an | |
| Does the subject have signs or symptoms consistent with Hepatitis? | |
| Has the subject recently experienced occupational or toxic exposure? | |
| Has the subject had a recent increase in alcohol use? | |
| Has the subject had a recent increase in recreational drug use? | |
| Have any local labs been performed that pertain to this event? | |
| Indicate the most severe Hepatobiliary AESI experienced by the Subject. | |
| Has there been a serological evaluation for viral hepatitis A, B, or C, | |
| Has a gastrointestinal or hepatobiliary consult occurred? | |
| Did the patient have any other additional required procedures? | |
| If yes, Specify the other additional required procedures | |
Form: Injection Site Reaction
| Question | Response |
|---|---|
| Date of assessment | |
| Did the subject have any injection site reacion events? | |
| What is the date of the injection? | |
| What date did the injection site reaction start? | |
| At what time did the injection site reaction start? | |
| What date did the injection site reaction end? | |
| At what time did the injection site reaction end? | |
| Was there pain (including burning) at the injection site? | |
| Was there itching at the injection site? | |
| Was there a rash (or redness) at the injection site? | |
| Was there hardening (that includes a knot or lump) at the injection | |
| Was there an open sore at the injection site? | |
| What was the laterality of the anatomical location of the injection | |
| What was the anatomical location of the injection site reaction? | |
Form: Chronic Kidney Diseaase History
| Question | Response |
|---|---|
| Medical Condition | |
| Date of diagnosis | |
| Stage of Chronic Kidney Disease | |
| What is the likely etiology of CKD? | |