Appendix EAbstraction Form Items

Publication Details

Study Characteristics

Refid

Author, Year

Key Question

Abstractor

Cancer type

Cancer Stage

Exp Drug v Control

Study Design

N Exp/Control

Age, Mean (SD); Median (range)

Treatment Efficacy and Safety

Primary Endpoint (Defined)

PFS, Experimental v Control, HR (95% CI)

OS, Experimental v Control, HR (95% CI)

ORR, Experimental v Control, % (95% CI)

Total Grade 3/4 AEs -- N (%) of pts on Experimental tx

Total Grade 3/4 AEs-- N (%) of pts in Control

QoL Description and PFS-QoL Association

QoL Tool Used

Threshold used for significant changes

Information on how the QoL was administered

Testing intervals for QoL, discontinuation criteria

QoL Timing for Drug treatment

QoL test (last administration) drop-out -- Experimental (N and % of total tx)

QoL test (last administration) drop-out -- Control (N and % of total tx)

Primary reasons for drop-out

Was Missing Data statistically addressed

PFS-QoL association descriptive results

PFS-QoL statistical method used