The trials were conducted in a variety of different types of cancer, with breast cancer being the most frequent (114 trials), almost double that of lung cancer (59 trials), which was the next most common.
Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings.
Mention of pharmacokinetic data collection was most frequent in records of trials that were Phase 1 (62%) or Phase 1 and 2 (57%).
In this trial, the most frequent toxicity was neutropenia: 4 patients (15%) had grade 4 neutropenia but without febrile neutropenia.
The most frequent adverse events in our trial were thrombocytopenia, diarrhea, and hand-foot-skin reactions, however, these events occurred less frequently in comparison to the safety reports from previous Sorafenib monotherapy trials.
In the PRIMA trial, the most frequent toxicities reported were grades 2 4 infection, occurring in 39% patients assigned to the MR arm, and in 24% on the observation arm (risk ratio 1.62; 95% CI: 1.35 1.96; P<0.0001.35 1.96
They are usually well tolerated, and the most frequent adverse event in clinical trials was nasopharyngitis.
Pain and tenderness at the injection site were the most frequent AE's in both trials.
The most frequent outcomes measured in these trials were QoL, depressive symptoms, anxiety, coping, and self-efficacy.
The most frequent shortcomings in the included trials were: omitting a description of the randomisation procedure, a lack of concealed allocation to groups and/or inadequate blinding.
