Authors
- Belinda Fazekas1,
- Linda Devilee1,
- David Currow2
- Palliative Care Clinical Studies Collaborative (PaCCSC)1,
- Flinders University2
2015
Excerpt
Aim
To identify all adverse (AE) and serious adverse events (SAE) reported since the commencement of the first clinical trial in 2008. To evaluate the event rate; severity: relatedness: patient withdrawals and reporting.
Methods
The reports from four completed studies were analysed to summarise: the event outcome: the severity grading; the relatedness to intervention; withdrawal rates and rates of reporting to HREC.
Results
Of the 735 participants, 177 (24%) experienced a total of 373 events, (198 AE, 175 SAE). A total of 55 (14%) events were assessed as being possible or probable to the study intervention. Sixty nine (9.3%) participants withdrew from the study as a result of an event. Cause was attributed to pre-existing symptoms, illness or medications in 156 cases (41%). Six participants died while on study, and three were unbli nded. There were no changes to the trial protocols related to safety.
Conclusion
PaCCSC has a comprehensive system for reporting adverse events and given the pre-existing illness burden of the participants, with few safety concerns. Clinical trials continue to play a critical role in expanding the evidence base for practice.
To identify all adverse (AE) and serious adverse events (SAE) reported since the commencement of the first clinical trial in 2008. To evaluate the event rate; severity: relatedness: patient withdrawals and reporting.
Methods
The reports from four completed studies were analysed to summarise: the event outcome: the severity grading; the relatedness to intervention; withdrawal rates and rates of reporting to HREC.
Results
Of the 735 participants, 177 (24%) experienced a total of 373 events, (198 AE, 175 SAE). A total of 55 (14%) events were assessed as being possible or probable to the study intervention. Sixty nine (9.3%) participants withdrew from the study as a result of an event. Cause was attributed to pre-existing symptoms, illness or medications in 156 cases (41%). Six participants died while on study, and three were unbli nded. There were no changes to the trial protocols related to safety.
Conclusion
PaCCSC has a comprehensive system for reporting adverse events and given the pre-existing illness burden of the participants, with few safety concerns. Clinical trials continue to play a critical role in expanding the evidence base for practice.