ABOUND 70+_Investigator Newsletter_ Data Entry Special Edition _02Feb16

Message to Investigators

Dear Abound.70+ Investigators and study teams,
Now that we are well into our enrollment phase of the study, we have put together a few reminders and notices related
to data entry which we hope you’ll find useful.

Upcoming iMedidata RAVE database modification: *IMPORTANT NOTICE*

As you may have already noticed, a database modification occurred last week. All sites need to review eCRF entries for
new queries or missing data. All issues must be resolved no later than Wednesday, 10 Feb 2016. The eCRF Guidelines
have been amended to reflect the updates.

 Please make sure all subjects have a laboratory facility selected for all lab pages, including chemistry,
hematology and unscheduled visits

 The 28-day follow-up folder will populate even if “withdrawal by subject” is selected for reason for treatment
discontinuation. Please ensure these pages are completed. If a subject does not complete the 28-day follow-up
visit for any reason, please indicate “not done” on the Date of Visit page.

 You may see new queries on the following forms: Radiation therapy; Central Chemistry; Local Hematology; Local
Chemistry; Histology; Treatment Disposition; Dosing Records. Please review and ensure responses are provided
for all queries.

As a reminder, there are still some outstanding issues from the previous database modification that need to be
addressed. These include:

 If a subject skips a dose of study drug (nab-paclitaxel and/or Carboplatin):
o ‘Was the dose administered?’ needs to be answered as No, and the reason for not taking dose must be
provided. Then, all other information should be deleted from the page.

 For dosing records where the subject received any amount of drug:
o ‘Was the dose administered?’ needs to be answered as Yes.

 Histology form- If ‘Mutational Gene Status known?’ is answered ‘Yes’, then data fields for each gene under this
question must be completed.

 Non-Target Lesions post screening form
o ‘Are there any Non-Target Lesions to report?’ must be answered for all assessment time points (at the
top of the form).

Tips and Reminders

The ABI-007-NSCL-005 eCRF Completion Guidelines have been provided as the primary resource for issues related to
data entry. If you are unsure of how to complete data entry or need additional support, please reach out to your
assigned PPD RSM or CRA.

 Adverse events that contain more than one unique condition (i.e., nausea and vomiting) should be recorded
as two separate medical conditions/events. A query will be issued to split and record the two events or a
medical diagnosis separately. (example: Fever and chills should be recorded as two separate events).

 The terms intermittent, recurrent, occasional, etc. are not recommended. All event occurrences should be
recorded as unique log lines.

 Record adverse events using medical terminology to provide the diagnosis. Do not record the individual
signs or symptoms of the diagnosis or syndrome. (Exception: Conditions associated with progression that
are considered AEs should be reported. Progressive disease itself or death are not considered AEs).
o For example, if the subject has a urinary tract infection with the following symptoms, burning on
urination; frequency of urination, fever and lower abdominal pain; the adverse event reported should
be ‘urinary tract infection.’
o Conditions or diagnoses should be captured for laboratory-related AEs when possible. For example, an
adverse event of elevated glucose should be recorded as ‘hyperglycemia’ rather than ‘elevated glucose.’

Abound.70+ Special Edition Newsletter Page 2

 If ‘Yes’ is selected for either sensory or motor neuropathy assessment, please ensure any worsening from
baseline is recorded on the adverse events log. New graphic

 Reporting AEs that result in dose modification/interruption: Not Applicable, Dose Not Changed and Dose
Reduced: Important examples
o Example 1
nab-Pac/Carbo was given on C1D1, nab-Pac was given on C1D8, nab-Pac skipped on C1D15 due to
AE. AE Actions taken for each study drug should be recorded as follows:
1. Action Taken with respect to Nab-Pac: Dose interrupted
2. Action Taken with respect to Carbo: Dose not changed

Note: C2D1 Carbo/Nab-pac may be dose reduced due to the AE experienced on C1D15 if it meets Dose
Mod Criteria in Section 8.3. In this case, The Action taken for that AE should be recorded as in Example 2:

o Example 2

Nab-Pac C1D15 dose was interrupted (skipped) due to AE. Subsequently, C2D1 nab-pac and carbo
doses were reduced

1. Action Taken with respect to Nab-Pac: Dose reduced
2. Action Taken with respect to Carbo: Dose reduced
3.
Note: Per eCRF Guidelines (p.66), “dose reduced” should be checked for AEs that result in both an
interruption in dosing and dose reduction in subsequent cycles

Abound.70+ Special Edition Newsletter Page 3

 ‘Not Applicable’ should only to be used for AEs occurring during Screening and follow up periods (after
treatment has been discontinued).
o Please refer to the dosing addendum at the end of the eCRF Guidelines for guidance on
skipped/delayed dosing.

 If patient experiences multiple AEs on a dosing day and treatment is modified or interrupted, please select
the primary AE that results in dose modification/interruption. There should be only up to 2 AEs that are
reported with an outcome of Dose reduced/Drug interrupted.

 All Medical History conditions that have an associated CTCAE grade and are ‘active’ should have a grade
recorded.

 Demographics: The following data are not automatically populated from Endpoint. Please make sure data
are entered into these fields for each subject.
o Protocol version, Ethnicity and Primary Race

 Laboratory results that are both abnormal and clinically significant should be recorded in the Unscheduled
Visit lab pages (if not already included under the Scheduled lab pages) and not on AE page. Only the
corresponding medical diagnosis should be recorded on AE page.

 If a subject received a Regimen of a combination of drugs, then all drugs in the combination Regimen should
have the same Regimen number. Each drug should have its own log line, while keeping the same Regimen
number. Additionally, Best Response for Regimen is expected to match. See example:

 Adverse Events that worsen or decrease in severity (grade)should be recorded as new AE records. Their
previous end dates should not overlap with their next start dates. The general rule should be that when an
AE increases or decreases in severity (grade), the date on which the severity changed (or was discovered to
have changed, as in the case of lab AEs) should be included as the start or end date for the more severe AE.

Abound.70+ Special Edition Newsletter Page 4