{"description":"VTd \\& DVTd (Part 1) arms contain the SAEs/AEs considered treatment emergent (TEAE) to Part 1 only from the 1st dose and before 2nd rando or subsequent therapy (ST), or after 2nd rando if TEAE related to the Part 1 treatment.\n\nVTd-DARA \\& DVTd-DARA (Part 2) arms include SAEs/AEs considered TEAE to Part 2, from the 2nd rando up to 30 days after the last dose prior to ST.\n\nVTd-OBS \\& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.","eventGroups":[{"deathsNumAffected":139,"deathsNumAtRisk":542,"description":"All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) and who received at least one dose of treatment.\n\nIt includes deaths that occurred from the 1st randomization to the end of the study.\n\nFor the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.","id":"EG000","otherNumAffected":529,"otherNumAtRisk":538,"seriousNumAffected":261,"seriousNumAtRisk":538,"title":"VTd - Part 1"},{"deathsNumAffected":83,"deathsNumAtRisk":543,"description":"All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) and who received at least one dose of treatment.\n\nIt includes deaths that occurred from the 1st randomization to the end of the study.\n\nFor the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.","id":"EG001","otherNumAffected":534,"otherNumAtRisk":536,"seriousNumAffected":264,"seriousNumAtRisk":536,"title":"DVTd - Part 1"},{"deathsNumAffected":48,"deathsNumAtRisk":215,"description":"All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to observation 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patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to observation group (OBS) at rando 2.\n\nIt includes deaths that occurred from the 2nd randomization to the end of the study.\n\nThat means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.","id":"EG004","otherNumAffected":198,"otherNumAtRisk":229,"seriousNumAffected":50,"seriousNumAtRisk":229,"title":"DVTd-OBS - Part 2"},{"deathsNumAffected":25,"deathsNumAtRisk":229,"description":"All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to daratumumab group (DARA) at rando 2 and who received at least one dose of treatment after Rando 2.\n\nIt includes deaths that occurred from the 2nd randomization to the end of the study.\n\nThat means that all deaths reported in this arm are also reported in the arm DVTd - Part 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