2. Overview of outcomes.
Outcome | Definition | Unit of outcome measurement | Referred to as/abbreviation | Prioritisation |
Complete control of nausea | No nausea and no significant nausea, as defined on a study levela Assessed for:
|
Binary; participants with complete control of nausea | No nausea | Overall phase prioritised for GRADE assessment |
Complete control of vomiting | No vomiting and no use of rescue medications Assessed for:
|
Binary; participants with complete control of vomiting | Complete response (CR) | Delayed and overall phases prioritised for GRADE assessment Overall phase chosen as most important efficacy outcome |
Quality of life | No impairment in quality of life during active study period | Binary; participants with no impairment in quality of life | QoL | Prioritised for GRADE assessment |
On‐study mortality | Deaths occurring from randomisation up to 30 days after the active study period | Binary; participants who died | OSM | Prioritised for GRADE assessment |
Adverse events | As defined on a study level; during active study period | Binary; participants with at least 1 event | AEs | ‐ |
Serious adverse events | As defined on a study level; during active study period | Binary; participants with at least 1 event | SAEs | Prioritised for GRADE assessment Chosen as most crucial safety outcome |
Neutropenia | As defined on a study level; during active study period | Binary; participants with at least 1 event | ‐ | ‐ |
Febrile neutropenia | As defined on a study level; during active study period | Binary; participants with at least 1 event | ‐ | ‐ |
Infection | As defined on a study level; during active study period | Binary; participants with at least 1 event | ‐ | ‐ |
Local reaction at infusion site | As defined on a study level; during active study period | Binary; participants with at least 1 event | ‐ | Prioritised for GRADE assessment |
Hiccup | As defined on a study level; during active study period | Binary; participants with at least 1 event | ‐ | ‐ |
aStandardised tools are typically used to assess degree of nausea and vomiting (Wood 2011). No nausea and no significant nausea were defined on a study level and typically refer to pre‐defined cutoffs, e.g. in Rapoport 2015 (a) or Schwartzberg 2015, nausea was assessed on a visual analogue scale (VAS; 0 to 100 mm; 0 = no nausea, 100 = severe nausea; < 5 mm = no nausea, < 25 mm = no significant nausea). No significant nausea is typically more subjective because of the wider range on the scale and is therefore less objective, especially in an open‐label study design. To increase comparability of studies and minimise biased results, we were therefore interested in patients with no nausea.