Serious Adverse Drug Reaction (SADR) Serious Adverse Drug Reaction (SADR)
A health issue, possibly caused by a medication, that leads to hospital care, lasting medical problems, life-threatening conditions, or death.
Example of Serious Adverse Drug Reaction (SADR) in a sentence
A Serious Adverse Drug Reaction is a major health problem that the study team thinks was likely caused by a study treatment
More Info
A Serious Adverse Drug Reaction (SADR) is reasonably likely to be caused by a study treatment and:
– results in death,
– is life-threatening,
– requires a person to stay in the hospital or lengthens their time in the hospital,
– results in ongoing or major disability or incapacity, or
– causes a birth defect.
In a research study, the study sponsor tracks and reports all adverse events and reactions so that there is a record of all the possible risks of the study treatment.
Other info to think about when joining a study
You may hear about Serious Adverse Drug Reactions (SADRs) if you are reading the results of what past studies have found.
You could also hear about SADRs if you are learning about the possible risks of being in a study that is testing a drug.
You should feel free to ask the study team about what they know about Serious Adverse Drug Reactions that could happen during the study.
