Additional study limitations include: i) heterogeneity of diseases and related-treatments, ii) reliance on predicted, and not measured, VO2max scores as indicators of aerobic fitness, iii) inaccurate patient reported outcomes, iv) the use of the Brief Fatigue Inventory to compare across cancer and non-cancer populations, and v) unreported pre-test protocol violations and use of PCMs.
Reasons for which a patient may discontinue participation in a study may include one of the following: Adverse events (moderate or severe) Abnormal laboratory values Abnormal test results Protocol violation Patient withdrew consent Lost to follow-up Patients have the right to withdraw from the study at any time for any reason, without the need to justify their decision.
Of the 124 patients enrolled, 121 (98%) were investigated with both the index test (PENT) and the reference standard (complete NCS-EMG) with no protocol violation.
However, it was felt that a longer gap between recruitment and testing would result in high attrition rates, and increased potential for protocol violation by participants (eg, by smoking or drinking liquids other than water).
Immunogenicity analyses at month 6 and month 6 + 21 d were performed on the according-to-protocol (ATP) cohort including vaccinated children without protocol violation and who complied with the vaccination and serological testing schedule.
Ten patients discontinued the study before test meal 2 at 24 weeks: four prandial + basal patients (two because of protocol violation, one because of an adverse event and one because of patient decision) and six basal patients (two because of perceived lack of efficacy, two because of move or loss of contact, one because of protocol violation and one because of patient decision).
This single patient received ASCT (protocol violation).
No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported.
Significant protocol violation or non-compliance.
Protocol violations will be recorded; data will be analyzed with and without patients with protocol violation.
