Skip to main content
. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

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:
  • acute phase: first 24 h of treatment with chemotherapy

  • delayed phase: after 24 to 120 h of treatment with chemotherapy

  • overall: 0 to 120 h of treatment with chemotherapy

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:
  • acute phase: first 24 h of treatment with chemotherapy

  • delayed phase: after 24 to 120 h of treatment with chemotherapy

  • overall: 0 to 120 h of treatment with chemotherapy

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.