{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}],"title":"Septic shock multi-organ failure"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"Acute myocardial infraction"},{"measurements":[{"groupId":"OG000","value":"2"}],"title":"Thrombocytopenia"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"No relevant event"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"Frequency of relevant toxicities. Toxicities will be classified according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. This endpoint will be evaluated from the start date of therapy and at any time during therapy and follow-up.","groups":[{"description":"Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.","id":"OG000","title":"One Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Monitoring planned after the first 5 patients treated.","reportingStatus":"POSTED","timeFrame":"the endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study","title":"Toxicity - Frequency of Relevant Toxicities","type":"SECONDARY","unitOfMeasure":"Participants"}