Additional Agent/Treatment/Intervention and/or Concomitant Medication Used That is Not Permitted Per Protocol

**Semantic type:** Conceptual Entity

**Definition:** A study protocol deviation where an additional agent/treatment/intervention and/or concomitant medication was used that is not permitted per protocol.

**Synonyms:** - Additional agent/medication and/or concomitant medication used that is not permitted per protocol - Additional agent/treatment/intervention and/or concomitant medication used that is not permitted per protocol